Scully, Sean M.D. 7/30/10

10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER

VIA UPS EXPRESS

JUL 30 2010

Sean Scully, M.D.
University of Miami Hospital
1400 North West 12th Avenue
Suite 2 Cedar Medical Center
Miami, FL 33136

Dear Dr. Scully:

This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at your clinical site from March 15, 2010, to April 15, 2010, by the investigators from the FDA's Florida District Office. The purpose of this inspection was to determine whether activities and procedures related to your participation in the clinical study entitled, "ReCap® Total Resurfacing System," Investigational Device Exemption (IDE) (b)(4) complied with applicable federal regulations. The ReCap™Metal-Metal Resurfacing is a device as that term is defined in section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 321 (h). This letter also requests prompt corrective action to address the
violations cited.

The inspection was conducted under a program designed to ensure that data and information contained in requests for IDE, Premarket Approval (PMA) applications, and Premarket Notification submissions (510(k)) are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.

Our review of the inspection report prepared by the district office revealed several violations of Title 21, Code of Federal Regulations (21 CFR) Part 812 - Investigational Device Exemptions. At the close of the inspection, the FDA investigators presented the inspectional observations Form FDA 483 for your review and discussed the observations listed on the form with you. The deviations noted on the Form FDA 483, and our subsequent review of the inspection report are discussed below:

1. Failure to conduct the investigation according to the signed agreement, the investigational plan, applicable FDA regulations, and any conditions of approval imposed by an Institutional Review Board (IRB) or FDA. [21 CFR 812.100 and 812.110(b)].

A clinical investigator is responsible for ensuring that an investigation is conducted according to the signed agreement with the sponsor, the investigational plan, applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA. You have failed to adhere to the above-stated regulations. Examples of your failures include, but are not limited to the following:

• The Study Protocol version, dated March 25, 2008, states that, "The safety of the system will be monitored by recording adverse events throughout the follow-up period. All adverse events, device related or otherwise; will be reported and recorded on the Adverse Event/Follow-Up Form." The Adverse Events Reporting section of the Investigator's Agreement, dated August 23, 2007, states that, "All adverse events, seemingly device-related or not, will be reported to Biomet." Subjects (b)(6), (b)(6), (b)(6), and experienced adverse events (AE). There is no documentation to show that the following AE's were recorded on the AE form and reported to the sponsor as required by the protocol and to the IRB as required by the IRB approval letter dated December 27, 2006.

o Subject visited your clinical site on April 30, 2008, ahead of her scheduled appointment, and again on September 10, 2008, because of a sensation of grinding in the hip.

o Subject visited your clinical site on March 19, 2008, and reported increasing lower back pain similar to his pre-operative symptoms.

o Subject visited your clinical site on May 27, 2009. The subject reported experiencing increasing right lower extremity pain that radiates to the dorsum of the right foot due to descending a ladder and having a hard landing. On October 7, 2009, the subject returned to your clinical site and reported to have several episodes of pain, particularly about the right hip in the anterior inguinal region. Again on February 17, 2010, the subject reported increasing right hip pain for a two-day period.

o Subject visited your clinical site on September 10, 2008. The subject reported increasing pain around the left hip and buttock, which had worsened over the last three months. The subject returned again on March 3, 2010, and reported pain with deep squats and with other maneuvers at extreme of flexion.

• The Study Protocol version dated March 25, 2008, states, "All adverse events, .device related or otherwise; will be reported and recorded on the Adverse event/Lost to Follow-up Form. The date and reason for the patient becoming "Lost to Follow-up will also be recorded on this form."

o Subject (b)(6) was implanted with the investigational device on November 20, 2007, and was scheduled for the follow-up visit for November 20, 2009, (b)(4). The subject did not return to the clinical site for the (b)(4) follow-up visit.

o Subject (b)(6) had the investigational device implanted on April 29, 2008, and was scheduled for the (b)(4) follow-up visit for April 29, 2009, (b)(4). The subject did not come to the clinical site for the first year annual follow-up visit.

Both of the above subjects were lost to follow-up; however, the "Lost to Follow-Up" form was not completed for either subject. In addition, there is no
documentation to show that you have attempted to contact or inquire about the subjects' follow-up visits.

2. Failure to maintain accurate, complete, and current records of each subject's case history and also failure to maintain complete and current protocol. [21 CFR 812.140(a)(3) and 812.140(a)(4)].

A clinical investigator is responsible for maintaining accurate, complete, and current records of each subjects' case history and exposure to the device, which encompasses the case report forms (CRFs) and supporting data. In addition, 21 CFR 812.140(a)(3)(ii) mandates that case histories shall contain all relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated). Also, a clinical investigator shall maintain complete and current protocol, with documents showing the dates of and reasons for each deviation from the protocol. You have failed to adhere to the above-stated regulations. Examples of your failures include, but are not limited to, the following:

• Your site did not complete the Harris Hip Score (HHS) 200 CRF for follow-up visits related to Subject (b)(6)(September 10, 2008, and May 6, 2009) and Subject (b)(6) (May 27, 2009, October 7, 2009, and February 17, 2010).

• The "Miller School of Medicine University of Miami - Orthopaedic History" form dated March 19, 2008, for Subject (b)(6) show that medications for blood pressure and diabetes were prescribed but the dose, reason for medication, and side effects of the medications were not recorded.

• Prior to FDA's inspection, the current version of the study protocol, dated March 28, 2008, for the ReCap® Total Resurfacing System, was missing or not maintained at your site. During the inspection, the sponsor provided your site with a copy of this protocol.

3. Failure to submit progress reports on the investigation to the sponsor and reviewing IRB at regular intervals. [21 CFR 812.150(a)(3)].

A clinical investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly. You have failed to adhere to the above-stated regulations. Examples of your failures include, but are not limited to, the following:

• During the period of August 18, 2008, through June 2, 2009, there was no IRB oversight of the ReCap® Total Resurfacing System study; therefore, no continuing report was submitted to an established IRB even though subjects were still completing their (b)(4) follow-up visits. In addition, there is no documentation on site to show that you have notified the sponsor of your request for study closure with the Western IRB nor was there notification of a lack of IRB oversight of the study during that time.

The violations described above are not intended to be an all inclusive list of problems that may exist with your clinical study. It is your responsibility as a clinical investigator to ensure compliance with the Act and applicable regulations.

Within fifteen (15) working days of receiving this letter, please provide written documentation of the additional actions you have taken or will take to correct these violations and prevent the recurrence of similar violations in current or future studies for which you are the clinical investigator. In addition, please provide a complete list of all clinical trials in which you have participated for the last five years, including the name of the study and test article, the name of the sponsor, the number of subjects enrolled, and the current status of the study. Failure to respond to this letter and take appropriate corrective action could result in the FDA taking regulatory action without further notice to you. In addition, FDA could initiate disqualification proceedings against you in
accordance with 21 CFR 812.119.

You will find information to assist you in understanding your responsibilities and planning your corrective actions in the FDA Information Sheets Guidance for Institutional Review Boards and Clinical Investigators, which can be found at http://www.fda.gov/oc/ohrtlirbs/. Any submitted corrective action plan must include projected completion dates for each action to be accomplished.

Your response should reference "CTS #(b)(4): " and be sent to: Attention: Linda Godfrey, Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring, 10903 New Hampshire Avenue, WO66-3462, Silver Spring, Maryland, 20993-0002.

A copy of this letter has been sent to the FDA's Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751. Please send a copy of your response to that office.

For further information concerning the Bioresearch Monitoring program, please visit our Internet homepage at http://www.fda.gov/cdrh/comp/bimo.html. Valuable links to related information are included at this site. The Division of Bioresearch Monitoring also developed introductory training modules in FDA-regulated medical device clinical research practices, which are available on the FDA website. The modules are for anyone involved in the clinical research enterprise and, can be found at http://www.fda.govlTraining/CDRHLearn/ucm162015.htm.

If you have any questions, please contact Ms. Linda Godfrey telephone at (301) 796-5490 or via email at Linda.Godfrey@fda.hhs.gov.

Sincerely yours,

/S/
Timothy A. Ulatowski

Director
Office of Compliance
Center for Devices and
Radiological Health

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M.I. Tech Co Ltd 7/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

 Warning Letter

Via United Parcel Service

JUL 29, 2010

Gim Chul Soo
President and CEO
M.I. Tech Co., Ltd
241-3 Habukri Jinwimyeon
Pyeongtaek,
Republic of Korea
451864

RE: Choostent Esophagus Asymetric (CCC)
Choostent Esophagus (CCC)
Choostent Esophagus (NCN)
Choostent Esophagus Upper (CCC)
Choostcnt Esophagus ST (CCN)
Choostent Esophagus Valve (CCC)
Choostent Esophagus Valve (CCN)
Choostent Colon/Rectum (CCC)
Choostent Colon/Rectum Asymmetric (CCC)
Hanarostent Esophagus Benign BS (CCC)
Hanarostent Esophagus Valve BS (CCC)
Hanarostent Biliary (NNN)
Hanarostent Biliary (CCC)
Hanarostent Biliary Lasso (CCC)
Hanarostent Biliary Hilar (NNN)
Hanarostent Duodenum/Pylorus (NNN)
Hanarostent Duodenum/Pylorus (NCN)
Hanarostent Intestine (CCC)
Hanarostent Colon/Rectum (NNN)
Hanarostent Colon/Rectum Asymetric (CCC)
Hanarostent Trachea/Bronchium (CCC)

Dear Mr. Gim:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Choostent Esophagus Asyrrietric (CCC), Choostent Esophagus (CCC), Choostent Esophagus (NCN), Choostent Esophagus Upper (CCC), Choostent Esophagus ST (CCN), Choostent Esophagus Valve (CCC), Choostent Esophagus Valve (CCN), Choostent Colon/Rectum (CCC), Choostent Colon/Rectum Asymmetric (CCC), Hanarostent Esophagus Benign BS (CCC), Hanarostent Esophagus Valve BS (CCC), Hanarostent Biliary (NNN), Hanarostent Biliary (CCC), Hanarostent Biliary Lasso (CCC), Hanarostent Biliary Hilar (NNN), Hanarostent Duodenum/Pylorus (NNN), Hanarostent Duodenum/Pylorus (NCN), Hanarostent Intestine (CCC), Hanarostent Colon/Rectum (NNN), Hanarostent Colon/Rectum Asymetric (CCC), and Hanarostent Trachea/Bronchium (CCC) [Choostents and Hanarostents] in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed promotional material you distributed at Digestive Diseases Week (DDW) 2010, from May 1-5, 2010, in New Orleans and internet websites for the above mentioned Choostents and Hamostents. These products are devices within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act. The Act requires that manufacturers of devices that are not exempt obtain marketing clearance or approval for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country.

These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IED) under section 520(g) of the Act, 21 U.S.C. 360j(g). These devices are also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).

You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and listing all promotional materials for the above mentioned Choostents and Hanarostents the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Paul Tilton at the Food and Drug Administration, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66-3520, Silver Spring, Maryland 20993-0002, facsimile at (301) 847-8137.We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that the above mentioned Choostents and Hanarostents comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely yours,

/s/

Tinothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

cc:
Brandon Choi
US Agent:
PATS CORP
49 Candlewood Way
Buena Park, CA 90621

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HSMG, Inc. D/b/a Smartinfuser USA

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128

July 29, 2010
 

Ref: 2010-DAL-WL-13

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Jeremy Kraus
President and General Manager
HSMG, Inc. dba Smartlnfuser USA
8588 Katy Freeway Suite 348
Houston, Texas 77024

Dear Mr. Kraus:

During an inspection of your firm located in Houston, Texas on November 17, 2009 through December 18, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports the Smartlnfuser PainPump™, SmartBlock™ PainPump, and accessories. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that your above-referenced devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and Title 21 Code of Federal Regulations (CFR) Part 803 - Medical Device Reporting (MDR) regulation.

We received a response from you dated January 13, 2010, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to submit a report to the FDA, as soon as practicable but no later than 30 calendar days after becoming aware that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 C.F.R. § 803.40(a). For example:

a. Your firm failed to submit an MDR report to FDA about an "overdose incident" that occurred in (b)(4) on January 16, 2009. Your firm became aware that the patient was over-infused with a pain medication over a short period of time while the device was on a fast prime function. The patient went later to a hospital's emergency room for medical treatment. Your firm reported that the device appeared to be on the prime position. Although the foreign manufacturer submitted to FDA an initial MDR report on May 7, 2009, and a supplement report on August 13, 2009, your firm, as an importer of the marketed device, should have reported the medical adverse event as an MDR on Form 3500A to the FDA, with a copy to the manufacturer, no later than February 17, 2009.

b. Your firm also failed to submit an MDR report to FDA for an "excessive infusion" incident that occurred at a hospital in (b)(4) on January 22, 2008. The patient was in a recovery room with a Smartlnfuser pain pump attached and had seizures. Your firm's incident report, dated January 22, 2008, states that you became aware that the patient had been over-infused with a pain medication in a short time due to a pump dispensing from the prime position. You stated to our investigator that the medical adverse event was due to user error. Your firm, as an importer of the marketed device, should have reported the medical adverse event as an MDR on Form 3500A to the FDA, with a copy to the manufacturer, no later than February 23, 2008. At the conclusion of the inspection on December 18, 2009, your firm had still not reported this medical adverse event to FDA.

2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. § 803.17. For example:

Your firm did not establish a written procedure to address the following: 1) documentation and recordkeeping requirements for handling and processing information on MDR reportable events, 2) for submitting complete and timely reports to FDA, and 3) for maintaining MDR event files and distinguishing them from other complaint records. Review of your firm's complaints revealed reports from the field involving patients and, therefore, potential health risks. During the inspection you acknowledged that your firm did not have written procedures for reporting individual events, investigating problems, and maintaining MDR files. Your firm did not appear to be knowledgeable about FDA's importer reporting requirements.

We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.

Our inspection revealed that your above-referenced devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:

1. Failure to submit a written report to FDA of any correction or removal of a device initiated to reduce a risk to health posed by the device, as required by 21 C.F.R. § 806.10(a)(1). For example:

Your firm failed to report to the Dallas District Office about a voluntary general recall of all Smartlnfuser™ PainPump and SmartBlock™ PainPump initiated on January 22, 2009. Your firm recalled these products because you received a report of over infusion of pain medication due to the user's incorrect use of the pain pump's fast priming feature on January 16, 2009. On January 22, 2008, your firm also received a similar report related to a patient overdose incident. In order to prevent serious injury or death to patients, your firm decided to remove these pain pumps from the market until you could provide adequate training to all dealers and sales agents, to ensure the appropriate use of the current fast priming feature. Your firm also received (16) reports of leaks in the pain pumps because of bonding defects. Leaks during patient usage can cause insufficient pain therapy and medical intervention.

We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.

This inspection also revealed that your firm is not registered with the FDA as a medical device initial importer. You must appropriately register your establishment as an initial importer of medical devices with the FDA. Failure to register as a device initial importer is a violation of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360. Information on how to register can be found at http://www.fda.gov/cdrh/devadvice/3122.html.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation (21 C.F.R. Part 820) deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

During this inspection the FDA noted some nonconformities which are deficiencies of the Quality System (QS) regulation found at 21 C.F.R. Part 820. These problems were reported to you and formally discussed with your firm's management. These nonconformities include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198(a). For example:

a. Your firm did not have a written complaint handling procedure for handling initial complaints and appropriate follow up, including Medical Device Reporting and corrective actions. You initially stated that your firm did not receive any complaints, but subsequently stated that incident reports from the field were kept electronically for business purposes. You stated that you had filed/labeled the incidents by Calendar (b)(4) since December 31, 2008 (b)(4) and (b)(4) to date), and by (b)(4) You also stated that the incident reports were labeled with a descriptive title and the date created. Your firm did not record complaints by number or in a complaint notification/incident report form to ensure that all information required by 21 C.F.R. Part 820.198 is documented and filed together.

b. You stated that the incident reports were typically leak issues. The inspection revealed that your firm had received approximately sixty (60) incidents since July 2007. Sixteen (16) incidents were related to leaks in the devices during patient use, and two (2) incidents involved over-infusion of pain medication. Your firm has not investigated these complaints as required by the Quality System regulation.

c. Your firm did not obtain and document the investigation details related to a product incident/return from a distributor. The distributor's RGA (return good authorization) form alleged that a pain pump from Lot #9009 was leaking from the reservoir and that the priming position of the regulator could not be locked to prevent "fast priming." Your firm could not confirm the leak, but confirmed that the "fast priming" was due to potential user error. Your firm contacted the foreign manufacturer to report the problems. Your firm and the foreign manufacturer agreed to retrieve (b)(4) pain pumps of Lot #9009 from the distributor. The foreign manufacturer requested from your firm (b)(4) new pain pumps from the lot remaining in inventory. The (b)(4) pumps were going to be used to help complete the investigation of the problems and to re-train the customer on how to safely use the pain pump regulator, as recommended by the manufacturer. Your firm could not provide evidence to demonstrate: that the (b)(4)new pain pumps were sent to the foreign manufacturer for testing; that the distributor returned the (b)(4) recalled pain pumps; and that your firm sent product replacements.

We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.

Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

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Dutch Valley Farms 7/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3100

 

July 29, 2010

WARNING LETTER

VIA UPS

Mr. Daniel Visser,
Owner
Dutch Valley Fanns
1271 State Road 288
Clovis, NM 88101

Ref. #: DEN-10-14

Dear Mr. Visser:

On June 22 - 24, 2010, the U.S. Food and Dmg Administration (FDA) conducted an investigation of your dairy operation located at 1271 State Road 288, Clovis, New Mexico. This letter notifies you of the violations of the Federal Food, Dmg, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act, and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. § 342(a)(2)(C)(ii)] a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, [21 U.S.C. § 360b]. Further, under section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically our investigation revealed that on (b)(4) you sold a dairy cow, identified with ear tag (b)(4) for slaughter as food to (b)(4).The dairy cow was slaughtered by (b)(4) United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.333 pmis per million (ppm) Sulfadimethoxine in the liver tissue.

FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the edible tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640, (21 C.F.R. 556.640). The presence of this drug in the edible tissues of this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Apt [21 U.S.C. § 342(a)(2)(C)(ii)].

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) ,of the Act [21 U.S.C. § 342(a)(4)].

We also found that you adulterated the new animal drug (b)(4) Sulfadimethoxine. Specifically, our investigation revealed that you did not use (b)(4) Sulfadimethoxine (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use, 21 C.F.R. § 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed, under the Act only if the extralabel use complies with  sections, 512(a)(4) and (5) of the Act, [21 U.S.C. § 360b(a)(4) and (5)], and 21 C.F.R. 530). including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation also found that you administered (b)(4) Sulfadimethoxine (b)(4) to a dairy cow without following the dose as stated in the approved labeling. Specifically, you treated the cow with nearly double the recommended dose. You extralabel use of (b)(4) Sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of (b)(4) Sulfadimethoxine  resulted in an illegal drug was not in conformance with its approved labeling and did not comply with 21 C.F.R.  Part 530, you caused the drug to be unsafe under section 512(a) of the Act, [21 U.S.C. §360(a)], and adulterated within the meaning of section 501(a)(5) of the act, [21 U.S.C. §351(a)(5)]

The above is not intended to be an-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injuntion.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation that corrections have been made.

You written response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, PO Box 25087, Denver, CO 80225-0087. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or email at william.sherer@fda.hhs.gov.

 

Sincerely,

/s/

 

H. Thomas warwick
Denver District Director

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Life Recovery Systems HD, LLC 7/28/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

WARNING LETTER
 

Robert J. Freedman, Jr., M.D., F.A.C.C.
President and Chief Executive Officer
Life Recovery Systems HD, LLC
150 Hopper Avenue
Waldwick, New Jersey 07463
 

Re: ThermoSuit Systems™

JUL 28 2010
 

Dear Dr. Freedman:
 

Refer to CTS #1000176 when replying to this letter

 

The Food and Drug Administration (FDA) has learned that your firm is marketing the ThermoSuit™ Systems in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 

The ThermoSuit™ System is a device within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act. The ThermoSuit™ System was cleared under K061023 and is intended for temperature reduction in patients where clinically indicated, e.g., in hyperthermic patients, and in monitoring patient temperatures. The ThermoSuit™ System is indicated for patients greater than 58" (147 cm) and less than 75" (190 cm) in height and less than 26" (66 cm) in width.
 

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed your Web site at http://www.life-recovery.com. which includes links to several advertisements from peer-reviewed journals, articles, and video presentations that promote the ThermoSuit™ System for new intended uses. A review of our records reveals that you have not obtained marketing approval or clearance for the uses promoted on your Web site, which is a violation of the law.
 

Specifically, your Web site promotes the ThermoSuit™ System for the prevention of permanent tissue and neurological damage, for increasing survival rate in cardiac arrest patients, and for limiting damage to the brain and tissues after cardiac arrest. The following claims may be accessed through your Web site's homepage and include, but are not limited to:
 

• "King's Daughters Medical Center has a groundbreaking new medical device to increase the survival rate of cardiac arrest patients. The ThermoSuit™ System rapidly cools the body temperature to limit damage to the brain and tissues after a cardiac arrest."(From http://www.kdmc.com/visitors/default.aspx?id=24380)
 

• "Although this study [which consists of conductive-immersion surface cooling using the ThermoSuit® System] was not designed to demonstrate impact on outcomes, survival and neurologic function were superior to those previously reported " (From Resuscitation Vol. 81: Issue 4, Pages 388-392)
 

• " ...the ThermoSuit System™ (TSS) from Life Recovery System (LRS) is a rapid non-invasive patient cooling device that reduces the risk of brain or heart damage." (From MedicalDevice-Network.com)
 

• "Ochsner is one of only about 50 medical facilities that use a novel cooling therapy called the ThermoSuit. ... [T]hat has translated into far lower rates of brain damage in patients at centers using the device."(Excerpted from the January 2010 issue of Good Housekeeping)
 

• "The ThermoSuit™ System is the most advanced technology to treat cardiac arrest patients today." (From Ochsner Health System press release dated May 6, 2008)
 

Additionally, your Web site contains a video promoting the ThermoSuit™ for the treatment of cardiac arrest patients. Specifically, the video states:
 

• "Emergency room staff at Ochsner Medical Center are using what is called a ThermoSuit™ in an effort to increase the survival rate of cardiac patients."
 

• Dr. Paul McMullen states: "So far, the only thing that hypothermia has been proven to help in human research is the brain in cardiac arrest. We believe that if one could lower the body temperature and lower the temperature of the heart tissue before the arteries reopen, then we could limit significantly the amount of damage that's done by the heart attack."
 

These claims cause the ThermoSuit™ to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The ThermoSuit™ is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for such uses, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 

The Office of Compliance requests that Life Recovery immediately cease the dissemination of promotional materials for the ThermoSuit™ System that are the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
 

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for ThermoSuit™ System that are the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to LCDR Michelle E. Noonan, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B, Office of Compliance at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, facsimile at 301847-8139. We remind you that only written communications are considered official.
 

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the ThermoSuit™ System comply with each applicable requirement of the Act and FDA implementing regulations.
 

Sincerely,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
 

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Closed Out Letter

• Life Recovery Systems HD, LLC- Closed Out Letter 10/7/10

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Gropoint Seafood Industries Sdn Bhd

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD

WARNING LETTER

JUL 27 2010

VIA OVERNIGHT MAIL

Ms. Adeline Tan, Chief Operating Officer
GroPoint Fisheries SDN BHD
Unit No.b2, Lot No. 205 3151 211,
Manmohan's Patau-patau Warehouse,
Labuan, Malaysia

Re: I.D. # 120208

Dear Ms. Tan:

In response to a request by the United States Food and Drug Administration for a copy of your firm's HACCP plan and supporting documents, including monitoring records, for your fish and fishery products, your firm responded by email on June 4, 2010 with the requested documents. Our evaluation of your HACCP plan and supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your scombrotoxin-forming fish, such as your tunas and Mahi Mahi, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

We note the following deviations:

1. You must conduct a hazard analysis to determine whether there are food safety hazard that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated or reduced acceptable levels." However, your firm's HACCP plan for your scombrotoxin-forming fish, such as your tunas and Mahi Mahi, does not list a critical control point for the overnight refrigerated storage of the fish, that is part of the carbon monoxide treatment, to control scombrotoxin formation.

Processing step (b)(4) that your firm provided clarifies that this step is an overnight refrigerated storage of the fish that is part of the carbon monoxide treatment. The document, however, dismisses the need for a critical control point for this operation by stating that the "temperature is covered by GMP" in the hazard analysis.

Any processing step that could result in the introduction of a food safety hazard should be identified as a critical control point in the HACCP plan. Overnight storage of scombrotoxin-forming fish in a reduced oxygen environment without temperature controls could result in scombrotoxin formation, as well as the growth and toxin formation of pathogens including Clostridium botulinum.

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for scombrotoxin-forming fish, such as your tunas and Mahi Mahi, lists monitoring procedures at the "Receiving at Dock" critical control point that are inadequate to control scombrotoxin formation.

Your firm uses a (b)(4) control strategy that rely on interviews with (b)(4) to document how the fish was handled during the (b)(4) fishing period. This does not represent an adequate control to prevent scombrotoxin formation in the fish. HACCP controls are intended to include monitoring procedures that ensure that the critical limits are being met and the records used to document the implementation of the monitoring procedures should include the actual values and observations obtained during monitoring and entered at the time the observation is made. Most of the elements included in your firm's "(b)(4)" that are pertinent to the listed critical limit could not be meaningfully observed or accurately and reliably recalled in detail without documentation of the real time observations by the harvest vessel operators. Your firm's monitoring approach through interviews after the fact does not provide assurances that the critical limits were met for fish received from the (b)(4) nor does it prevent receipt of time or temperature abused fish where the fish could have formed excessive scombrotoxin or where the time or temperature abuse permitted growth and enzyme production of the organisms that will form scombrotoxin.

In addition, chilling on board should bring the fish to 4.4oC or below (not (b)(4) or below as listed in your firm's HACCP plan) and held at that temperature for the duration of the fishing trip.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).

However, the corrective actions listed in your HACCP plan at the "Plant Receiving and Wash Fish" critical control point are not appropriate to control scombrotoxin formation. Your firm relies on visual inspections of the adequacy of ice surrounding the fish when the fish are received at the processing facility after transport from the wharf by truck. Your firm's corrective action plan states, (b)(4) ..."

The listed corrective action suggests that your firm does not understand the importance of the listed critical limit of ensuring adequate ice surrounding the fish at receipt at the processing plant and instead to default to the corrective action of taking internal temperatures in the situations when the critical limit associated with ice is not met. Taking internal temperatures offish at the point of receipt is not generally a reliable means of ensuring the safe handling of fish throughout the entire transit time. Moreover, the listed corrective action procedures do not ensure that the cause of a critical limit deviation is corrected.

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ial6120.html.

This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

During our review, we also identified the following issues:

1. At the "Receiving at Dock" critical control point, your HACCP plan lists (page 8), "Maximum fish exposure temp. was less than (b)(4) as one of the critical limits. Your firm's "Product Description" (page 4 of the firm's HACCP plan) identifies that the fish are "caught... in [the] (b)(4)." Our data indicates that the air temperatures in that region of the world are routinely in excess of (b)(4). Exposures to these temperatures will reduce the recommended exposure time for safe handling of the fish to (b)(4) after death of the fish. While this should not present an obstacle for hand-line type of fishing operation, it may affect the critical limit and the type of recordkeeping applicable to your operations.

2. (b)(4) from the wharf to the processing plant. Your firm may want to give further consideration to its hazard analysis for this processing step.

For example, the hazards and controls associated with "Plant Receiving" and "Wash Fish" may be distinct operations and might better be considered independently rather than combined as they currently are in the HACCP plan.

In addition, if the transport of the fish is extremely fast from the wharf to the processing facility, such that time or temperature abuse leading to hazards is not reasonably likely to occur, there might not be a need for a critical control point for this processing step. However, before concluding this, you should consider not only the physical time of transport, but the time of exposure of the lot from the time the first fish of the truckload is removed from the controlled iced environment of the hold of the harvest vessel being off-loaded until the time the last fish of the truckload is restored to a controlled temperature environment in a firm's processing scheme. Because your firm does not include a raw fish storage step, the next operation that the fish return to a controlled temperature environment may be the (b)(4) processing step. Consequently, under the circumstances, you may be dependent on control of the temperatures via proper icing of the fish from the wharf to the processing facility, and possibly, beyond if the fish are held on the trucks prior to processing, similar to a storage operation.

3. Your firm's HACCP plan specifies the use of chlorinated water from (b)(4) as a component of the critical limit for pathogen controls at the "Plant Receiving and Wash Fish" critical control point. However, neither the monitoring procedures in the plan nor the monitoring records provided call for or show that the chlorine concentration is monitored. When a firm has identified the need for chlorine control to control the pathogen hazard at this processing step, the control should be measured and recorded as part of the HACCP plan.

4. A the "Receiving at Dock" critical control point (pages 8 - 9) of your HACCP plan, your firm lists, "At least quarterly submit (b)(4) of finished product for histamine testing by a certified independent laboratory" as a component of the verification procedures.

Histamine is most likely to be detected at elevated levels in the lower anterior loin of fish that have been time and temperature abused in a manner that permits scombrotoxin formation. Waiting until the fish are further processed, e.g. butchered, portioned, and packaged, such that the lower anterior loin is no longer discernable in the final product substantially reduces a processor's opportunity to use the histamine testing verification procedure to obtain assurances that the fish it receives and processes are safe. To be an effective scombrotoxin control at the receiving critical control point, collection of the samples to be tested on the fish is important. FDA recommends that:

• A minimum of (b)(4) to be tested should be collected. Portions collected from other areas on the fish are far less likely to detect elevated histamine levels even in time or temperature abused fish.

• The entire (b)(4) should be individually ground from which the test aliquot can be obtained from the comminuted result of each sub-sample.

In addition, the best opportunity for your firm to conduct the quarterly verification would be on those occasions when a marginally acceptable lot is received or a lot containing some fish discerned to have undergone some time or temperature abuse rather than a lot full of pristine fish. In addition, we suggest that processors collect a verification sample of (b)(4), rather than the (b)(4) listed in your HACCP plan, for routine histamine sampling for processors that elect the histamine testing control strategy.

5. Your firm's monitoring procedures at the "Receiving at Dock" critical control point (page 9) of the HACCP plan, state, in part, that a "minimum of (b)(4) are to be measured for "internal temperature" with "every lot received" from the harvest vessels. The monitoring procedures parenthetically also state "(One lot is defined as all the fish of a single species unloaded from one harvest vessel for this HACCP plan.)."

In review of your records, it appears that you are not following this procedure. For examine, one of the monitoring records provided for (b)(4) of tuna received on April 27, 2010, from the (b)(4)", shows the recording of internal temperatures of only (b)(4) from the lot of tuna, not the minimum of (b)(4) listed in your HACCP plan. This appeared on other processing dates as well.

It is not clear whether your firm is fully implementing its HACCP plan in this regard. Because different species of fish have very different morphology and cooling curves, it would be prudent to ensure an adequate representation of each species of fish is measured for internal temperature.

Please send your reply to the Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov

Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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Eaton Manufacturing Corporation Dba Eaton Medical

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New Orleans District 404 BNA Drive Building 200, Suite 500 Nashville, TN 37217 Telephone: 615-781-5385 FAX: 615-781-5391

July 27, 2010

WARNING LETTER NO. 2010-NOL-17

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Bron Eaton, President
Eaton Manufacturing Corporation
dba Eaton Medical
1401 Heistan Place
Memphis, Tennessee 38104-4729

Dear Mr. Eaton:

On June 23 & 25, 2010, an investigator from the United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1401 Heistan Place, Memphis, Tennessee. This inspection determined you manufacture post mydriatic protective eyewear and contact lens cases, which are medical devices as described under Section 201 (h)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 321(h)(2)] because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

The devices you manufacture are adulterated under Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with 21 Code of Federal Regulations, Part 820 (21 CFR 820), Quality System (QS) regulations. The Act and related device regulations can be found through links at our Internet homepage at www.fda.gov.

On June 25, 2010, a Form FDA 483, Inspectional Observations, was issued to (b)(6) Warehouse Manager. A photocopy of this document is enclosed for your reference. The serious deviations noted during the inspection include, but are not limited to, the following:

1. Failure to establish QS procedures and instructions [21 CFR 820.20(e)]. There are no written quality system procedures and instructions for the manufacture and distribution of your contact lens case device.

2. Failure to develop and implement Medical Device Reporting procedures (21 CFR 803.17).

3. Failure to establish written procedures for Corrective and Preventive Action [21 CFR 820.100(a)]. There are no measures in place to investigate a device non-conformance and determine the disposition and preventive course for recurrence of the device failure.

4. Failure to establish and implement written procedures for acceptance of incoming products [21 CFR 820.80(b)]. There is no assurance of the identity and quality of the incoming devices since there are no tests or verification steps to assure the devices meet established specification requirements.

5. Failure to establish written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit [21 CFR 820.198(a)]. There is no complaint handling system to investigate complaints and determine the disposition of the issue at hand.

6. Failure to establish written procedures to ensure all purchased or otherwise received product and services conform to specified requirements (21 CFR 820.50). There are no specifications for purchasing controls.

7. Failure to establish device history records (21 CFR 820.184). There is no documentation of the manufacture of each device.

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations which exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of Federal law and FDA regulations. Other agencies may take this warning letter into account when considering the award of contracts. Recurrence of the aforementioned deviations may result in legal action without further notice, including, without limitation, seizure and injunction.

You are requested to notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to prevent the recurrence of violations or similar violations. Please explain and include documentation of any corrective action you have taken. If these corrective actions will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.

Please send your reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.

Sincerely,
/S/
H. Tyler Thornburg
District Director
New Orleans District

cc: (b)(6), Warehouse Manager
Eaton Manufacturing Corporation
dba Eaton Medical
1401 Heistan Place
Memphis, TN 38104-4729

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Biomet, Inc. 8/13/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

 

WARNING LETTER

 

Jeffrey R. Binder
CEO
Biomet. Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581
 

JUL 27 2010
 

RE: Signature™ Personalized Patient Care system
Refer to GEN 0901195 when replying to this letter.
 

Dear Mr. Binder:
 

The Food and Drug Administration (FDA) has learned that your firm is marketing the Signature™ Personalized Patient Care system in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website. www.biomet.com. for the Signature™ Personalized Patient Care system. The product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act.
 

The Signature™ Personalized Patient Care system is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
 

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 

The Office of Compliance requests that Biomet, Inc. take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
 

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. We remind you that only written communications are considered official.
 

Your response should be sent to:
 

Matthew Krueger
Chief, Orthopedic and Physical Medicine Devices Branch
Center for Devices and Radiological Health
WO 66, Room 3676
10903 New Hampshire Avenue
Silver Spring, MD 20903-0002
 

If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or fax number (301) 847-8138.
 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 

Sincerely,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
    Radiological Health
 

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Biomet, Inc. - Close out letter

• Biomet, Inc. - Close out letter

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Nitrox, Inc.

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

July 26, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter: SEA 10-27

Mr. Bill Evan McAllister, President
Nitrox, Inc.
2706 164th Street Southwest
Lynnwood, Washington 98037-7808

WARNING LETTER

Dear Mr. McAllister:

During our March 22, 2010 through April 19, 2010 inspection of your manufacturing facility located at 2706 164th Street Southwest, Lynnwood, Washington 98037, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP.

Specific violations observed during the inspection include, but are not limited to, the following:

1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release [21 C.F.R. § 211.165(a)]. For example, your firm does not perform finished product testing on filled cylinders of Dolonox, a 50% USP Nitrous Oxide and 50% USP Oxygen compressed medical gas mixture, prior to release. From September 2003 to May 2009, your firm released (b)(4) high-pressure cylinders of Dolonox without testing the product for identity and strength.

2. Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 C.F.R. § 211.160(b)].

For example, your firm has not established appropriate written procedures to test liquid Nitrogen NF for assay and limit of Oxygen. Your firm's only written Standard Operating Procedure (SOP) for testing liquid Nitrogen NF specifies that the Splitter Test is to be used for identity testing. The Splitter Test is not considered a scientifically sound test method. Further, during the inspection, you told our investigators that the standard practice for assay testing of liquid Nitrogen NF was to use (b)(4) handheld analyzers. However, you could not provide documentation of (b)(4) handheld analyzer testing. Please note that the FDA does not consider the (b)(4) handheld analyzer to be an acceptable test method for the assay of liquid Nitrogen NF because your firm has not demonstrated that it is equivalent to the monograph test method for assay.

3. Your firm did not prepare batch production and control records for each batch of drug product produced, including documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished [21 C.F.R. § 211.188(b)]. For example, your firm manufactures Dolonox without producing batch production and control records to document performance of the necessary cylinder prefill checks such as visual examination, dead ring test for corrosion, prefill odor check, and vacuum evacuation.

4. Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess [21 C.F.R. § 211.100(a)]. For example, your firm has not established written procedures for the manufacturing, testing, and distribution of Dolonox.

5. Your firm did not have drug product production and control records reviewed and approved by a Quality Control Unit (QCD) to determine compliance with all established, approved written procedures before a batch is released or distributed [21 C.F.R. § 211.192]. For example, your firm's QCU did not review or approve batch production records for liquid Nitrogen NF distributed between November 24, 2009, and February 19, 2010.

6. Your firm did not follow written production and process control procedures in the execution of the various production and process control functions [21 C.F.R. § 211.100(b)]. For example, SOP "Medical Gas Supplier Audit Report" requires your Firm to audit your medical gas supplier every However, your firm has not conducted audits of your supplier of liquid Nitrogen NF.

Additionally, under section 510 of the Act [21 U.S.C. § 360], manufacturers of drug products are required to annually register with the FDA. Our records indicate that you have not registered your establishment since April 22, 2008. Therefore, liquid Nitrogen NF and Dolonox are misbranded according to section 502(o) [21 U.S.C. § 352] in that they were manufactured in an establishment not registered as required under section 510 of the Act [21 U.S.C. § 360].

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility, until the above violations are corrected. FDA may reinspect to verify corrective actions have been completed.

Please note that several of the violations described above were cited in FDA-483s issued at the conclusion of the October 2003 and March 2000 inspections. The most recent inspection found that your firm has failed to implement sufficient corrective actions and many of the same violations persist.

In addition, you admitted to our investigators that your firm does manufacture and distribute Dolonox. In your response, please list which specific medical gas products your firm intends to manufacture and how you plan to meet FDA's regulations for these medical gas drug products. Your response should also state if your firm no longer manufactures or distributes the drug product(s) manufactured at this facility, and if your firm destroyed or removed any of your drug product(s) from the market following the most recent inspection. Please also provide the date(s) and reason(s) your firm performed such action(s).

The violations cited in this letter are not intended to be an all-inclusive list of deficiencies that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.

Your reply should be sent to the following address: Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington 98021-4421, to the attention of Brenda L. Reihing, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Reihing at (425) 483-4899.

Sincerely,
/S/
Charles M. Breen
District Director

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Flowers Baking Company of Villa Rica, LLC

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309

 

July 22, 2010
 

VIA UNITED PARCEL SERVICE

George E. Deese, Chairman of the Board/CEO
Flowers Foods
1919 Flowers Circle
Thomasville, GA 31757
 

WARNING LETTER
(10-ATL-18)

Dear Mr. Deese:

On February 09 - 10, 2010, the U.S. Food and Drug Administration conducted an inspection of your Flowers Baking Company of Villa Rica, LLC facility, located at 134 Doyle McCain Drive, Villa Rica, Georgia 30180. During this inspection our investigator collected a sample of Nature's Own Honey Wheat Enriched Bread, manufacturer code 113041, to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA's web page at www.fda.gov

FDA analyzed the sample of your Nature's Own Honey Wheat Enriched Bread to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states one serving (1 Slice/26 grams) contains 0.5 gram of total fat. However, the sample analysis performed by FDA found 0.733 gram of total fat per serving (original analysis) and 0.806 gram of total fat per serving (check analysis). The original analysis was 47% and the check analysis was 61% in excess of the total fat amount declared on your product's label. The analytical worksheets for sample number 512517 are enclosed. Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading because the amount of total fat present is greater than 20 percent in excess of the declared value (21 CFR 101.9(g)(5)).

This letter is not intended to be an all-inclusive review of your firm's products and their labeling. It is your responsibility to ensure that your firm and your products comply with the Act and FDA regulations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice. For instance, we may take further action to seize your product and/or enjoin your firm from operating.

You should notify this office in writing, within 15 working days of receipt of this letter, of any corrective actions, including an explanation of each step being taken to prevent the recurrence of similar conditions. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within 15 working days, state when the corrections will be completed and the reason for your delay.

Please send your reply to Derek C. Price, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, GA 30309. If you have any questions about the content of this letter please contact Mr. Price at 404-253-227, derek.price@fda.hhs.gov.
 

Sincerely

/S/

John R. Gridley
District Director
Atlanta District Office

cc: Mr. Randy Brock, Plant President
Flowers Baking Company of Villa Rica, LLC
134 Doyle McCain Drive
Villa Rica, GA 30180
 

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Close Out Letter

• Flowers Baking Company of Villa Rica, LLC - Close Out Letter 9/28/11

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Boca Pharmacal Inc. 7/22/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	555 Winderley Place, Ste. 200 Maitland, Florida 32751 Telephone: (407) 475-4700 FAX: (407) 475-4769

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Warning Letter

July 22, 2010

Mr. Bob J. Edwards Jr, CEO
Boca Pharmacal, Inc.
3550 NW 126th Avenue
Coral Springs, Florida 33065

Dear Mr. Edwards:

On February 23, 2010, FDA issued a warning letter to (b)(4) (copy attached). As explained more fully in that warning letter, certain drug products that (b)(4) has manufactured are new drugs that lack approved applications as required under the Federal Food, Drug, and Cosmetic Act (the Act). Based on information obtained during FDA's inspection of (b)(4) in September 2009, your firm contracted or otherwise arranged with (b)(4) to manufacture one or more drug products that your firm distributes. These drug products include, but are not necessarily limited to:

• Pseudo DM GG Syrup (Dextromethorphan Hydrobromide 15 mg, Pseudoephedrine Hydrochloride 40 mg, Guaifenesin 100 mg)

• C-Phen DM Drops (Chlorpheniramine Maleate 1.0 mg, Phenylephrine Hydrochloride 3.5 mg, Dextromethorpan Hydrobromide 3.0 mg)

The above products are drugs within the meaning of section 201 (g) of the Act, [21 U.S.C. § 321(g)] because, as demonstrated by their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. Based on our information, there are no FDA-approved applications on tile for these drug products.

Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates section 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by (b)(4) and may apply to all drug products that you market without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.

Your reply should be sent to Winston R. Alejo, Compliance Officer.

Sincerely,
/S/
Emma R. Singleton

Director, Florida District
 

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U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods 7/21/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Avenue Jamaica, NY 11433

 

July 21, 2010

Warning Letter NYK-2010-24

VIA Vnited Parcel Service

Michael Endico, President
U.F.S. Industries Inc. d.b.a. Sally Sherman Foods
300 N. MacQuesten Parkway
Mount Vernon, NY 10550-1008

Dear Mr. Endico:

We inspected your seafood processing facility, located at 300 N. MacQuesten Parkway, Mount Vernon, NY 10550-1008 between March 29 and April 8, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your refrigerated ready-to-eat (RTE) fishery products packed in oxygen-limiting containers including tuna salad, seafood salad, and cream cheese and lox are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your HACCP plan that includes your tuna salad, seafood salad, aud cream cheese and lox spread that are packaged in oxygen-liniiting containers, does not list the food safety hazards of Clostridium botulinum growth and toxin formation, allergens, and additionally, for the tuna salad, scombrotoxin (histamine) formation.

Once you have identified these hazards, your HACCP plan must also include appropriate critical control points, establish critical limits, and identify monitoring procedures and record keeping to ensure control of these food safety hazards as required by 21 CFR 123.6(c).

In addition, these products contain allergenic ingredients such as milk, wheat and eggs, which must be declared on finished product labels as required by section 201(qq) of the Act, 21 U.S.C. 321 (qq). Consequently, as are result FDA recommends that firms include a packaging/labeling critical control point in their HACCP plans to conduct a visual check for allergen declarations on each lot of product labels

Furthermore, the oxygen transmission rate of your packaging listed in your package specifications from the packaging manufacturer, (b)(4), is not sufficiently oxygen permeable to create an aerobic environment that will prevent Clostridium botulinum growth and toxin formation. FDA recommends that the minimum oxygen transmission rate of packaging film to ensure prevention of the hazard of Clostridium botulinum growth and toxin formation should be  10,000cc/m²/24 hrs. In the absence of adequately permeable packaging, FDA recommends secondary controls (i.e., in addition to refrigeration) for Clostridium botulinum growth and toxin formation. The use of validated time-temperature integrators on each consumer package is also an appropriate means of providing adequate control. Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, can help you determine a method of control that is best suited to your process.

2) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However,

a. Your HACCP plan that includes seafood salad does not list the critical control point of:

i. Cooking the scallops for controlling the food safety hazard of pathogen growth and toxin formation.

ii. Post-cook Pre-mix cooling of the scallops for controlling the food safety hazard of pathogen growth and toxin formation.

b. This same HACCP plan includes cream cheese and lox spread and does not list the critical control point of post-cook pre-mix cooling of the lox for controlling the food safety hazard of pathogen growth and toxin formation.

3) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points to comply with 21 CFR § 123.6(c)(3). A critical limit is defined in 21 CFR § 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your HACCP plan that includes cream cheese and lox spread, lists a critica limit, (b)(4) at the cooking critical control point, however the plan does not list whether the temperature limit is for the product internal temperature or the heating media temperature. Additionally, the plan does not list a critical limit for the cooking time required to control the food safety hazard of pathogen growth and toxin production.

4) You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your HACCP plan  that includes tuna salad, seafood salad and cream cheese and lox spread lists a monitoring procedure and frequency, (b)(4) with a (b)(4) at the "Cooling/Storage" critical control point that is not adequate to control pathogen growth and toxin formation.

FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage. Intermittent temperature checks as a monitoring procedure during refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks. FDA also recommends a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly.

5) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, the corrective action listed in the plan for tuna salad seafood salad, and cream cheese and lox spread, (b)(4) at the "Cooling/Storage" critical control point to control pathogen growth and toxin formation (and histamine formation in tuna salad), is not adequate. Your listed corrective action, does not resolve how the cause of the deviation will be corrected, or ensure that no product enters commerce that is injurious to health or is otherwise adulterated as a result of the deviation.

6) You must verify that your HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented, to comply with 21 CFR Part 123.8 (a). Specifically, your firm must conduct, or have conducted for you, a scientific study to establish a cooking process for the lox (smoked salmon) ingredient in the your cream cheese and lox spread that ensures that the internal product temperature of all product in each batch will achieve the desired and measured heat exposure required to eliminate pathogens growth and toxin formation. However, during our inspection of-your facility, you stated to the investigator that no validation study was conducted to verify that your cooking process is adequate to control the food safety hazards. FDA recommends establishing, by scientifically validated studies, critical limits for minimum length of cook cycle as a "time" component and minimum critical limit for "temperature" of cooking media, such as water, steam, or oil, in your particular cooking equipment. Other critical factors that affect the heating rate of the product, such as maximum thickness of the smoked salmon trimmings, minimum initial internal temperature of product before presentation to the cooker, and maximum number of pieces placed in the cooker, may also be established by the study. These critical factors would then be established as your critical limits and would be the target of your measured monitoring procedures in your HACCP plan.

7) You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 110.40 (a) and 110.80 (b)(13)(iv). However, you did not monitor prevention of cross-contamination from insanitary objects as evidenced by: On March 30, 2010, our investigator observed a thick white dressing leaking from an overhead product transfer pipe in the finished product packaging room into an open hopper of ready-to-eat coleslaw salad. Furthennore, the thick white dressing was observed to come in contact with black electrical tape (partially covering the leak on the pipe) and old product residue on the pipe before dripping into ready-to-eat coleslaw salad.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter.Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and vetification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the eafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo,NY 14202. If you have questions regarding any issues in this letter, please contact Dean Rugnetta at 716-541-0324.

Sincerely,

/s/

Ronald M. Pace
District Director
New York District

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Close Out Letter

• U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods- Close Out Letter 1/20/11

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