Newport Lobster Company, Inc. 2/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New England District One Montvale Avenue Stoneham, Massachusetts 02180 FAX: (781) 587-7556 Phone: (781) 587-7500

WARNING LETTER

NWE-11-11W

VIA UPS Next Day Air

 

 

February 28, 2011

 

Mr. Kenneth Haslam

President

Newport Lobster Company, Inc.

1076 Aquidneck Avenue

Middletown, RI 02842-5204

 

Dear Mr. Haslam:

 

We inspected your seafood processing establishment, located at 1076 Aquidneck Avenue, Middletown, RI on November 23 through December 15, 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 ready-to-eat cooked lobster meat products, tuna and pasteurized crabmeat products 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 implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the routine cooking of lobster meat or the presence of ice twice daily at the cooler storage critical control point to control pathogens listed in your HACCP plan for RTE cooked lobster meat, RTE pasteurized crabmeat, and raw tuna. For example:

 

a. Your firm had no monitoring records for the routine cooking of lobster meat at your facility. Your HACCP plan indicates that records will be completed to assure that the cooking critical limits (CL’s) are met, yet you indicated that these records are not maintained. 

 

b. HACCP plans for three of your high risk seafood products, ready to eat (RTE) cooked lobster meat, RTE pasteurized crabmeat and raw tuna, all indicate that you will monitor the presence of ice twice daily at the cooler storage critical control point (CCP). During the inspection we observed that you were not recording this data twice a day.   We also observed a number of days that had no monitoring data for this CCP.

 

c. HACCP plans for two of your high risk seafood products, RTE pasteurized crabmeat and raw tuna, indicate that you will monitor presence of ice or cooling medium for RTE pasteurized crabmeat and the presence of ice and temperatures for raw tuna at the receiving step of these products. Your firm had no monitoring records for the receiving of these products at your facility.

 

2.  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, your corrective action plans for RTE pasteurized crabmeat and raw tuna at the “Cold Storage/Holding” critical control point are not appropriate. The corrective actions for the critical control points of these products lists “ICE DOWN & MONITOR,” “EVALUATE PRODUCT SAFETY,” and “CORRECT CAUSE OF ANY PROBLEM.”  Your corrective action plans do not list how you intend to correct the cause of the deviation, for example by discontinuing the use of the suppliers.

 

In addition, none of your corrective actions list measures to ensure that potentially adulterated products do not enter into commerce. For example your corrective action plans do not reference product disposition when products are found to have exceeded the critical limits.

 

3.  Failure to maintain sanitation control records which, at a minimum, document the monitoring and correction of eight key sanitation principles, as required by 21 CFR 123.11(c). Your firm did not have any monitoring data for the months of January, February, March, April, May, June, July, August, October and November 2010 that included the monitoring data of the following eight sanitation principles:

 

a. Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

b. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

c. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;

d. Maintenance of hand washing, hand sanitizing, and toilet facilities;

e. Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological compounds;

f. Proper labeling, storage, and use of toxic compounds;

g. Control of employee health conditions that could result in the microbiological contamination of food, food packaging material, and food contact surfaces; and

h. Exclusion of Pests from the food plant.

 

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 have done, since your August 18, 2010 correspondence, to correct these violations. You should include in your response documentation such as HACCP and verification 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 seafood 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: Karen N. Archdeacon, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.

 

 

Sincerely,

/S/ 

  

Mutahar S. Shamsi

District Director

New England District

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Close Out Letter

• Newport Lobster Company, Inc.- Close Out Letter 10/24/11

-

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Evershing International Trading Inc. 2/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700

       

February 28, 2011

 

 

VIA UPS

 

 

David H. Hua, President

Evershing International Trading Inc.

950 South 3^rd Street

San Jose, CA 95112

 

WARNING LETTER

 

Dear Mr. Hua:

 

We inspected your seafood importer establishment, located at 950 South 3^rd Street, San Jose, California, on December 15 - 20, 2010.  We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your fish sauce and frozen salted fish are adulterated under Section 402(a)(4)of the Act, 21 U.S.C. § 342(a)(4), 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 are as follows:

1. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i).   However, your firm imports fish sauce from Thailand and you do not have product specifications to address the hazard of histamines.
2. You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the importation of your Fish Sauce imported from (b)(4); and your Frozen Salted Fish imported from (b)(4). Your affirmative step for each of these products is maintaining a copy of the foreign processor’s HACCP plan, in compliance with 21 CFR 123.12 (a)(2)(ii) (D). However in order to fully comply with 21 CFR 123.12 (a)(2)(ii) (D) you must also maintain a copy, in English, of a written guarantee from the foreign processor indicating that the imported fish and fishery product was processed in accordance with the FDA seafood HACCP regulation; and your

Please be advised that products that are frozen and packaged under oxygen impermeable films need to display thawing instructions, indicating that the products should be thawed under refrigeration and used immediately to reduce the likelihood for Clostridium botulinum toxin formation during thawing.

 

For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 3^rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

 

We may take further action if you do not promptly correct this violation. 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," seize your product(s) and/or enjoin your firm from further violating the Act.

 

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 importer verification records and records that document the performance and results of your firm’s affirmative steps, 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 seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

 

Please send your written reply to the Food and Drug Administration, Attention: Sergio Chavez, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.

 

Sincerely,

/S/ 

Barbara J. Cassens

District Director

 

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Thurmond-Anderle, Margaret E. M.D. 2/25/11

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

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ref: 11-HFD-45-02-05

Margaret E. Thurmond-Anderle, M.D. 
6701 Woodward Street
Amarillo, TX 79106

Dear Dr. Thurmond-Anderle:

Between August 17 and August 20, 2010, Mr. Joel Martinez, representing the Food and Drug Administration (FDA), conducted an investigation and met with you to review your conduct of the following clinical investigations of the investigational drug (b)(4) performed for (b)(4).:

Protocol (b)(4), entitled “(b)(4)”;

Protocol (b)(4) entitled “(b)(4)”; and

Protocol (b)(4) entitled “(b)(4).”

This inspection is a part of FDA's Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of the human subjects of those studies have been protected.

From our review of the establishment inspection report, the documents submitted with that report, and your written response dated August 23, 2010, we conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. We are aware that at the conclusion of the inspection, Mr. Martinez presented and discussed with you Form FDA 483, Inspectional Observations. We wish to emphasize the following:

You failed to conduct the studies or ensure they were conducted according to the investigational plans, and to protect the rights, safety, and welfare of subjects [21 CFR 312.60].

Protocol (b)(4)  required that a pharmacist or appropriately qualified person prepare and provide infusion bags containing 200 mg (6.7 mL) of study medication or placebo. Our investigation revealed that your office manager, who is not a pharmacist and does not appear to be appropriately qualified to prepare infusion bags, inaccurately prepared the study drug or placebo for infusion at approximately one-tenth of the protocol-specified dose. You acknowledged this dosage error in your correspondence to the sponsor dated July 21, 2008, in which you explained that the error resulted from the use of an inappropriately-sized syringe. Apparently, your office manager was instructed by the registered nurse to use a 1-mL syringe to achieve greater accuracy of the 0.7-mL measurement. However, she [the office manager] mistakenly used this 1-mL syringe, instead of a 10-mL syringe, for all measurements. You acknowledged the error and admitted to the sponsor that study results for the one subject enrolled into the study were impacted.

In your August 23, 2010, written response, you outlined corrective measures to prevent future recurrence of this finding. We note, however, that in your written response, you did not adequately address the preventive measures you would take to ensure that only appropriately qualified individuals are involved in the preparation of study drugs. In addition, we request that you provide additional information regarding the pervasiveness of the dosage error. In particular, you did not explain whether the dosage error extended to Protocols (b)(4) and (b)(4), for which the same office manager prepared study infusion bags; you did not say how many subjects’ dosages were impacted; and you did not give the period of time over which the errors occurred. Inaccurate preparation of study drugs not only compromises the reliability of the data captured at your site, but could also significantly jeopardize subject safety.

This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address these deficiencies and establish procedures to ensure that any ongoing or future studies will be in compliance with FDA regulations.

Within fifteen (15) working days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to adequately and promptly explain the violations noted above may result in regulatory action without further notice.

If you have any questions, please contact Constance Cullity, M.D., M.P.H., at 301-796-3397; FAX 301-847-8748. Your written response and any pertinent documentation should be addressed to:

Constance Cullity (formerly Lewin), M.D., M.P.H.
Branch Chief
Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993

Sincerely yours,
{See appended electronic signature page}
Leslie K. Ball, M.D.
Director
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
 

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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
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/s/
----------------------------------------------------
LESLIE K BALL
02/25/2011
 

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Ohio Fresh Eggs LLC 2/25/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Cincinnati District Office 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2775

February 25, 2011

 

VIA UPS OVERNIGHT

 

WARNING LETTER

CIN-11-160313-05

 

John W. Glessner, CEO

Ohio Fresh Eggs, LLC

10513 Croton Road

Johnstown, OH 43031

 

Dear Mr. Glessner:

 

From November 2 through November 29 and on December 20, 2010, the Food and Drug Administration (FDA) reviewed records of your shell egg production operation. The review was initiated after 13 FDA environmental samples from four of your egg layer sites were confirmed positive for Salmonella Enteritidis (SE). We found that you have serious deviations from the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (shell egg regulation), Title 21, Code of Federal Regulations, Part 118 [21 CFR 118]. The failure to adequately implement the requirements in 21 CFR 118 causes your shell eggs to be in violation of the Public Health Service Act, (the "PHS Act"), Title 42 U.S.C. Section 264(a). In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.A. 342(a)(4), in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, the PHS Act, and the shell egg regulation at www.fda.gov.

 

The significant deviations were as follows:

 

1. You failed to divert eggs to a treatment that achieves a 5-log destruction of SE upon receiving notification that any of your four egg tests were positive for SE, as required by 21 CFR 118.6(d). Specifically, your firm’s egg testing at Site (b)(4), House (b)(4) resulted in two consecutive SE-positive egg tests. Your firm became aware of the first SE-positive egg test result on October 4, 2010. However, your firm shipped 798 cases of eggs from House (b)(4), on October 7, 2010 to a table egg processor, rather than an egg treatment facility. After our investigators brought this to your attention, you initiated a recall of the eggs on November 5, 2010.

 

2.   You failed to label the pallet, case, or other shipping container, containing eggs being diverted to treatment, with the statement, "Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f),” as required by 21 CFR 118.6(f). Specifically, you diverted eggs from the following locations without the required labeling:

Site #	House #	Circumstances of Diversion
(b)(4)	(b)(4)	+ SE egg sample	10/04/2010 – 10/28/2010
(b)(4)	(b)(4)	+ SE environmental sample and no subsequent egg testing under § 118.6(a)	10/26/2010 – 11/07/2010
(b)(4)	(b)(4)	+ SE environmental sample and no subsequent egg testing under § 118.6(a)	10/26/2010 – 11/02/2010
(b)(4)	(b)(4)	+ SE environmental sample and no subsequent egg testing under § 118.6(a)	09/22/2010 – 09/28/2010
(b)(4)	(b)(4)	+ SE environmental sample and no subsequent egg testing under § 118.6(a)	09/22/2010 – 10/04/2010

This letter may not list all of your firm's deviations. You are responsible for ensuring that your firm  operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

 

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 corrections.

 

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.

 

Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter please contact Mr. Rabe at 513-679-2700 ext. 163.

 

 

Sincerely,

/S/

Teresa C. Thompson

District Director

Cincinnati District

 

 

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Medela Inc 2/25/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863

 

February 25, 2011

 

WARNING LETTER

 

CHI-06-11

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

Carr Lane Quackenbush

President

Medela, Inc.

1101 Corporate Drive

McHenry, Illinois 60050

 

Dear Mr. Quackenbush:

 

During an inspection of your firm located in McHenry, Illinois from October 4, 2010 through November 1, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures breast pumps, breast pump kits, and pediatric feeding devices (breast milk storage products) for human use. Under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], these products are defined as 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. 

 

The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding are not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), part 820. 

 

We received a response from Carr Lane Quackenbush, President and Donald Alexander, Vice President Quality Management and Regulatory Affairs, dated November 22, 2010, concerning our investigator’s observations noted on the Form FDA 483, 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 adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

 

For example:

 

a. Complaint remediation activities initiated in July of 2010 have identified (b)(4) complaints. Quality data contained within these complaints have not been analyzed to identify existing and potential causes of nonconforming product or other quality problems. Fourteen Pump in Style Advanced (PNSA) electric breast pump complaints document motors and transformers smoking or catching fire;

 

b. Actions needed to correct an in-process inventory of PNSA printed circuit boards (PCBs) identified as containing potential defects associated with (b)(4) (which could cause low vacuum, loss of vacuum, or the pump’s inability to power on) were not identified. After distribution of product manufactured from this inventory of PCBs, Return Material Authorization (RMA) returns for issues associated with this PCB increased from an average of (b)(4).

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to update and establish new CAPA and related procedures, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to look at retroactive CAPAs, determine if new CAPAs would need to be opened, and evaluate related procedures and subsystems to determine if they also need to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.

 

2. Failure to adequately establish and maintain complaint files, including procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). 

 

For example:

 

a. (b)(4) of a sample of (b)(4) Return Material Authorizations reviewed (b)(4) communicated alleged deficiencies related to quality, reliability, or performance of Pump in Style Advanced (PNSA) and Freestyle electric breast pumps. These communications were not recognized as complaints by your firm’s customer service representatives or servicing technicians nor documented as complaints on customer complaint/issue form (b)(4).

 

b. Complaint files do not document the complete nature and details of complaints or an explanation of the efforts made to ascertain the information. Complaint File Nos. (b)(4) document alleged pain and injury events yet do not document the patient outcome including whether medical intervention was necessary or your firm’s efforts to ascertain this information.

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to establish new Complaint Handling and Adverse Event Reporting procedures, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all previous complaints and MDRs, determine the cause for why proper information is not being gathered for complaints, and evaluate related procedures and subsystems to determine if they also need to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.

 

3. Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). 

 

For example, your firm’s risk assessment for the Pump and Save breast milk bags used with the Pump in Style Advanced (PNSA) pumps did not consider the effect of (b)(4) on the performance of the storage bags.

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to update the Risk Management program, conducted certain risk assessment studies, and provided an action plan with a timeline to remedy the issues mentioned above, the data did not support your firm’s conclusions as it did not adequately address all the concerns and was not gathered with any statistical rationale. Your firm also failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the risk assessment process to determine if other components were lacking, review other risk assessments for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.

 

4. Failure to adequately establish and maintain a design history file (DHF) for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR 820, as required by 21 CFR 820.30(j). 

 

For example, the Pump in Style Advanced (PNSA) DHF did not contain or reference design input requirements, design outputs (including outputs essential to the proper functioning of the device and the device master record), or the results of design verification and design validation.

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer both the Design Control Quality System and the Change Control Quality System by reviewing and updating necessary design procedures, expanding (b)(4) to include the observation from the FDA 483, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the design history file to determine if other components were lacking, review other device history files for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.

 

5. Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e).

 

For example, your firm conducts in-process testing “Vacuum Performance Testing – Double Pumping Vacuum requirements” on each Pump in Style Advanced (PNSA) electric breast pump to verify proper functionality. These in-process test results are not documented in the device history record (DHR).

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer the Production and Process Control Quality system by April 2011, and indicated that each PNSA pump is now individually tested to fully verify the device is performing as intended and PNSA breast pump production will restart once the production line verification and validation activities are complete, your firm failed to assure that all test results are documented in the DHR. Your firm also failed to provide an actual timeline for completing the verification/validation testing. In addition, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the DHR to determine if other required activities were also not documented, review other DHRs for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. Your firm also did not provide evidence of implementation of all of the planned actions.

 

6. Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.

 

For example:

 

a. Visual aid instructions for the Pump in Style Advanced (PNSA) assembly process were in use without approval.

 

b. At the time the PNSA breast pump was first launched (August 2003), the functional testing performed for the pump included verification testing for both the stimulation and expression modes according to PNS OQM Checklist (b)(4) Functional Testing, dated 08/26/2003. All of the stimulation mode verification tests as well as the expression mode single pumping tests were removed from (b)(4) in December 2007. No Document Change/Release Order was generated to control this change as required by your firm’s Document Change Order (b)(4).

 

We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer the Labeling, Document and Change Control System, create a Device Master Record Index protocol, and create a Labeling protocol, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the document control procedures to determine if other components were lacking, evaluate all instructional aid to ensure they had all been approved and unapproved instructions had been adequately disposed, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.

 

Our inspection also revealed that your electric breast pumps are misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act (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 803 – Medical Device Reporting (MDR) regulation.  Significant deviations include, but are not limited to, the following:

 

1.   Failure to report to us no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device you market may have caused or contributed to a death or serious injury, as required by 803.50(a)(1).

 

For example:

 

a. Complaint (b)(4) describes that the patient sought medical attention and was prescribed antibiotics and pain medication. Based on the lack of evidence indicating that treatment with a prescription antibiotic was not necessary to preclude permanent impairment of a body function or permanent damage to a body structure, the referenced complaint meets the definition of a serious injury.

 

b. Complaint (b)(4) describes a patient who was diagnosed with mastitis. Mastitis is an inflammation of the breast usually caused by a bacterial infection. Literature review indicates that “Mastitis will not go away without treatment.” Without additional information from you indicating that (1) the device did not cause or contribute to the mastitis, and/ or (2) that treatment is not necessary to preclude permanent impairment of a body function or permanent damage to a body structure, we conclude that complaint (b)(4) meets the definition of a serious injury. 

 

We reviewed your response and conclude that it is not adequate because while your firm submitted MDRs for complaint (b)(4) and complaint (b)(4), your firm failed to correctly identify the event type in Block H.1 of the FDA Form 3500A. The event type listed in both MDRs is identified as “Other” when it should have been identified as “Serious Injury”. Your firm will need to submit a supplemental report for each MDR in order to correct this error.

 

2.   Failure to report to us no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device you market has malfunctioned and this device or similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 803.50(a)(2).

 

For example, Complaint (b)(4) states that during use the device caught on fire and smoke came out the sides of the motor. Complaint (b)(4) describes that the (b)(4) caught on fire. The information in these complaints reasonably suggests that the reported malfunctions are likely to cause or contribute to a death or serious injury if they were to recur.

 

We reviewed your response and conclude that it is not adequate because your firm failed to submit malfunction MDRs for complaint (b)(4) and complaint (b)(4) which involved reports of fire.

 

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 violations 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) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken.  If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities.  If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.

 

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 management systems.  You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance. 

 

Your response should be sent to: Lorelei Jarrell, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15^th Floor, Chicago, IL 60661. If you have any questions about the content of this letter, please contact Ms. Jarrell at 312-596-4216.

 

 

Sincerely,

/S/                                                          

Scott J. MacIntire

District Director

 

 

cc:      

Mr. Donald Alexander

VP Quality Management & Regulatory Affairs

Medela, Inc.

 

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Cenova Innovation and Productions AB 2/25/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Ave. Silver Spring, MD 20993-0002

FEB 25 2011 

 

WARNING LETTER

 

Via United Parcel Service

 

Mr. Mats Lindgren

General Manager

Cenova Innovation and Productions AB

4, Florettgatan

SE-595 43 Mjolby,

Sweden

 

Dear Mr. Lindgren:

 

During an inspection of your firm located in Mjolby, Sweden, on September 13-15, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a contract manufacturer and packager for class II and III medical devices. The subject device is the “CoreTherm” System Microwave Thermotherapy for Benign Prostatic Hyperplasia (P010055/S006).  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 these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  We received a response from you, dated September 20, 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 establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).  

 

Specifically, Corrective and Preventive Action Procedure 3-9900-040, rev. 5, dated December 12, 2008, does not contain adequate provisions to:

 

1.)    Analyze quality data (e.g., complaints and nonconformances/internal deviations) with appropriate statistical methodology where necessary to detect recurring quality problems; and

 

2.)    Ensure corrective actions are verified or validated to ensure that such action is effective and does not adversely affect the finished product (e.g., Internal Deviation Nos. 111 and 349)

 

The adequacy of the firm’s response, dated September 20, 2010, cannot be determined at this time.  You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for statistical analysis, investigations, and documentation no later than October 30, 2010. However, documentation has not been provided to show the update.  

 

2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

 

Specifically, Corrective and Preventive Action Procedure 3-9900-040 rev. 5, dated December 12, 2008, does not contain adequate provisions to ensure:

 

1.)    Nonconformances are adequately investigated (e.g., Internal Deviation 310 and 181); and

2.)    Persons or organizations responsible for nonconformances are notified of the nonconformances (e.g., Internal Deviation 310)

 

The adequacy of your firm’s response, dated September 20, 2010, cannot be

determined at this time.  You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for investigations and documentation no later than October 30, 2010.  However, documentation has not been provided to show the update.

 

3. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).

 

For example, batch number (b)(4) was reworked when returned from your customer due to a weld nonconformance.  You did not establish a rework procedure for reworking and repackaging this lot. The reworked lot was mislabeled and returned to your firm's customer. The customer returned the lot a second time due to mislabeling.

 

The adequacy of your firm’s response, dated September 20, 2010, cannot be determined at this time.  You stated that a procedure for rework will be created no later than October 30, 2010.  However, no documentation has been provided to show the procedure for rework.  Additionally, your firm has not informed FDA of any specific plan or provided evidence addressing global systemic corrective actions for rework of nonconforming products.

 

 

4.  Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

 

Specifically, Corrective and Preventive Action Procedure 3-9900-040 rev. 5, dated December 12, 2008, (used for handling complaints) does not contain provisions to ensure complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications are adequately investigated.  Four of eleven customer complaints reviewed (Complaint Nos. 251, 246, 230, and 180) were not fully investigated and/or documented.

 

The adequacy of your firm’s response, dated September 20, 2010, cannot be determined at this time.  You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for investigations and documentation no later than October 30, 2010.  However, documentation has not been provided to show the update.

 

5. Failure to adequately document revalidation activities when changes or process deviations occur, as required by 21 CFR 820.75(c).

 

Specifically, inspections and tests (visual, pull, and dye penetrant) were conducted to support a change in the weld time for a validated packaging process and were summarized in a test report dated June 21, 2010. The source data used to generate the test report were not documented or maintained.

 

We have reviewed your response, dated September 20, 2010, and have concluded that it is inadequate because it does not adequately address the requirements of 21 CFR 820.75(c), nor has your firm provided the FDA with evidence of immediate corrections and systemic corrective actions. You stated that the root cause was due to negligence of the tester and that all staff making tests and validation would be retrained in the requirement of always saving data. Although you plan to retrain the staff, you have not addressed a global systematic approach to Change Control Procedure 3-9900-024.

 

You should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations 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.  Section 801(a) of the Act (21 U.S.C. § 381(a)).  Also, U.S. 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 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.  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 actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.  If the documentation is not in English, please provide a translation to facilitate our review.

 

Your response should be sent to: Paul Tilton, 10903 New Hampshire Avenue, WO-66, Room 3540, Silver Spring, Maryland 20993. If you have any questions about the content of this letter please contact: Paul Tilton at 301-796-5770.

 

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 yours,

                                                           

/S/                       

                                                                       

Steven D. Silverman

Director

Office of Compliance

Center for Devices and

Radiological Health

 

 

 

 

-

InSight Dairy, LLC. 2/24/11

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

February 24, 2011

WARNING LETTER NYK-2011-18

VIA United Parcel Services

Christopher A. and Jessica A. Fredericks, Owners
InSight Dairy, LLC.
682 Newville Road
Little Falls, New York 13365-4614

Dear Mr. and Ms. Fredericks,

On January 4 and 6, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 682 Newville Road, Little Falls, New York 13365-4614. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FDA’s web page at www.fda.gov.

We found that you offered for sale animals for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 or about July 19, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 20, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 12.95 parts per million (ppm) of neomycin residue in the kidney. In addition, our investigation revealed that on or about August 2, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about August 3, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.53 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) in bob veal calves, and there is no acceptable level of residue associated with the use of this medicated milk replacer in veal calves. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 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 FD&C Act, 21 U.S.C. 342(a)(4).

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

Our investigation found that you fed (b)(4) containing neomycin sulfate to both bob veal calves with back tags #(b)(4) without following the approved labeling. The extralabel use of (b)(4)containing neomycin sulfate was in or on feed, in violation of 21 C.F.R. 530.11(b), and the extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because this use of (b)(4) containing neomycin sulfate was not in conformance with the approved labeling, you caused the drug in the feed to be unsafe under section 512(a)(1) of the FD&C Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). In addition, you caused the animal feed containing the neomycin sulfate to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6).

The above is not intended to be an all-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 food you distribute is 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 injunction.

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 of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean R. Rugnetta at (716) 541-0324 or Email at Dean.Rugnetta@fda.hhs.gov.

Sincerely yours,

/S/
Ronald M. Pace
District Director
New York District
 

-

Gordon Food Service, Inc. 2/24/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

 

WARNING LETTER
2011-DET-06

February 24, 2011

VIA UPS

My. James D. Gordon, President/Owner
Gordon Food Service, Inc.
333 50th Street, SW
Grand Rapids, MI 49548

Dear My. Gordon:

We inspected your seafood processing facility, located at 7770 Kensington Court, Brighton, MI 48116-8416 on October 29 through November 12, 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, 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 tuna salad and refrigerated raw shucked scallops 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 or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."

• However, your firm's HACCP plan titled "HACCP PLAN FOR PROCESSED SEAFOOD" for refrigerated tuna salad does not list the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.
 

We note that your "HACCP PLAN FOR PROCESSED SEAFOOD" consists of a Hazard Analysis Worksheet which incorrectly concludes that no hazards were identified for any of your processing steps. In your November 23, 2010, letter in response to the FDA 483 observations, you indicate that your "tuna salad items...are made with cooked tuna" and "There is no hazard for histamine production in cooked tuna." Proper retorting of the tuna in cans or retort pouches will destroy pathogens, organisms and enzymes responsible for scombrotoxin formation. However, once the can or pouch of retorted tuna is opened and exposed to recontamination from the air, processing environment, and the inclusion of other ingredients during the making of the tuna salad product, pathogens and organisms responsible for scombrotoxin formation are reintroduced to the tuna meat, and given uncontrolled time-temperature conditions conducive to growth, the hazards are once again likely to occur. In addition, because your tuna salad is a ready-to-eat product, pathogen growth and toxin formation are reasonably likely hazards that your firm needs to control with an effectively implemented written HACCP plan.

For additional information related to the hazards of histamine (scombrotoxin) formation, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.

• However, your firm's HACCP plan titled "HACCP PLAN FOR INVERTEBRATE GROUP 2," for refrigerated (iced) raw shucked scallops meat in metal cans does not list the food safety hazard of Clostridium botulinum toxin formation.

Your document titled "HACCP PLAN FOR INVERTEBRATE GROUP 2" consists of only a Hazard Analysis Worksheet which incorrectly concludes that no hazards were identified as pertinent to any of your processing steps. The raw scallop meat containers observed by FDA investigators at your facility were metal containers with friction closure lids similar to paint cans. In your November 23, 2010, letter in response to the FDA 483 observations, you indicate that your "fresh canned scallops...do not have the risk of C. botulinum because they are in a can similar to a paint can that has not undergone thermal processing, so it is not an anaerobic environment that would support the growth of C. botulinum." FDA recognizes that the product in these cans has not undergone a thermal process. In the absence of an adequate thermal process, Clostridium botulinum bacteria and spores will not have been destroyed and, therefore are expected to be viable in the containers of product. We understand that there was no known vacuum drawn or gas injection (controlled or modified), nor thermal application (e.g. hot fill), applied when packaging the product whereby a reduced oxygen environment was deliberately created in the closed can. However, while there may initially be trapped oxygen when the can is sealed, and there may be some oxygen transmission through the non-hermetically sealed lid ridge, there will also be a consumption of available oxygen during normal respiration of bacterial activity in the raw product, especially if the product is subject to abusive time-temperature exposures. Because the metal can itself is clearly not oxygen permeable and, while there may be the possibility of slight oxygen replenishing at the surface of the container through the lid seal, the development of an anaerobic environment conducive to the botulinum toxin hazard deeper in the can is considered reasonably likely. Unless your firm has scientific evidence to show that the oxygen transmission through the lid seam is sufficient to inhibit Clostridium botulinum growth and toxin formation throughout the container during time-temperature abuse, or that spoilage of the product in these containers will occur well in advance of toxin formation during time-temperature abuse, than your firm needs to control the hazard with an effectively implemented written HACCP plan.

For information concerning the hazards of pathogens and Clostridium botulinum toxin formation please refer to chapters 12 and 13 of the Hazards Guide.

We note that your hazard analyses do not distinguish between refrigerated and frozen product which could affect the hazards that need to be controlled. Also, while your hazard analyses suggest that all the fish and fishery products handled by your firm are intended to be fully cooked by consumers, if you identify any of your buyers to be associated with the raw consumption market, your hazard analysis of the affected refrigerated products may well identify previously dismissed hazards that you may need to control through an appropriate written and implemented HACCP plan.

In addition, your firm might consider regrouping your products for hazard analysis purposes on the basis of hazards germane to your operation as a secondary processor and include process, package, and potential end-use related hazards that could affect the controls pertinent to your products.

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 plans for Vertebrate Groups 6, 7, 8, and 9, which cover various scombrotoxin (histamine) forming fish, list monitoring procedures and frequencies, that are not adequate to control scombrotoxin formation. Specifically,

• At the "Receiving" critical control point, your HACCP plan lists "Visual examination" for the "Adequacy of ice surrounding product" in "Every lot at receiving." However, the monitoring procedures do not instruct how many units are to be examined in each lot received. FDA recommends monitoring of a sufficient number of containers (e.g. cartons) to represent all of the product in the lot. Your monitoring records should provide a positive reflection of the number of units examined compared to the number of units in the lot, or a percentage of units examined, to properly document the actual observations made were sufficiently representative of the lot.
 

• At the "Storage" critical control point, your HACCP plan lists only a "Daily" "Visual examination" for the "Adequacy of ice surrounding product." FDA recommends a monitoring frequency of at least twice daily checks for adequacy of ice during refrigerated (iced) storage. Again, the monitoring should be of a sufficient number of containers (e.g. cartons) from each of the lots to represent all of the product in all of the lots in the storage coolers. Your monitoring records should provide a positive reflection of the number of units examined compared to the number of units in each lot and the number of lots in the coolers, to properly document that the actual observations made were sufficiently representative of all lots. In a very large warehouse, this can become cumbersome to accomplish in a meaningfully manner. But, because various lots may contain products of different sizes and configurations and residence time and exposures in the coolers, control is achieved only by sufficient coverage during monitoring. Your firm may want to consider if continuous time-temperature monitoring devices in the coolers, with appropriate critical limits, may be a more advantageous monitoring strategy for refrigerated storage of your fish and fishery products.

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 action plans listed in your HACCP plans for Vertebrate Groups 6,7,8, and 9,10, and 11, which cover various scombrotoxin (histamine) forming fish, at the receiving and storage critical control points, are not appropriate to control scombrotoxin (histamine) formation are not appropriate. Specifically,

• The corrective actions listed at your "Receiving" and your "Storage" critical control points, state "Reject product" and "Destroy product," respectively. Unless 100% of the product is examined during the monitoring, the inference of the units examined should extend to the entire lot and appropriate corrective action should, therefore, be taken on the entire lot accordingly, not just on portions of product that happened to be observed with inadequate ice.

• Your listed corrective actions do not address how the cause of a critical limit deviation will be corrected. FDA recommends that, in addition to rejection of the lot at receipt, that you discontinue use of the supplier until evidence is obtained that transportation handling practices have been improved. Likewise, FDA recommends that, in addition to destruction of the lot at storage, that you take additional steps (e.g., make repairs or adjustments to the cooler, or modify the process) to regain control over the operation and to prevent reoccurrence of the deviation.

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.
 

In addition, we offer the following comments based on our review of your HACCP plans and your manufacturing operations.

1. FDA did not include your herring product from Vertebrate Group 10 or your snapper product from Vertebrate Group 11 in the above citations despite your identifying them with the scombrotoxin (histamine) hazard. The herring were not listed above because your "HACCP PLAN FOR VERTEBRATE GROUP 10" states that the product is "Stored and shipped in a frozen state." We note that this conflicts with your "Hazard Analysis Worksheet" and "HACCP Plan Form" that follow which address the fish as if it is in the refrigerated state. If, in fact, you receive and store the herring in a refrigerated state, the scombrotoxin citations above, as well as other potential hazards depending on the packaging and intended use, may be pertinent to the herring product. The snapper were not included in the letter because FDA has determined that snapper do not present a scombrotoxin (histamine) hazard.

2. We note that your firm's HACCP plans for Vertebrate Groups 6, 7, 8, and 9, which cover various scombrotoxin (histamine) forming fish, do not list adequate verification procedures and frequencies at your "Receiving" or "Storage" critical control points to verify the effective implementation of the monitoring procedures of "Visual examination[s]" for the "Adequacy of ice surrounding product" to control the hazard of scombrotoxin (histamine) formation. FDA recommends that processors relying on visual checks of ice or cooling media to monitor adequate cooling of product, periodically measure internal temperatures of fish to ensure that the ice or cooling media is sufficient to maintain product temperatures at 40°F or less. A good time to conduct these verifications is when lots are observed with marginally acceptable levels of ice or coolant. Verification checks of the temperatures of product should be directed at any exposed edible portions of fish and near surface temperatures of the fish as well as deep core temperatures.

3. Investigators observed potential sanitation monitoring and record-keeping deficiencies at your facility during the inspection. Your firm should ensure that it complies with the sanitation control procedures provisions of 21 CFR 123.11. While all eight elements of sanitation may not be applicable to your operations, you must monitor conditions and practices, and maintain sanitation control records, for those elements that are applicable to your operations.

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 verification 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 seafood 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 U.S. Food and Drug Administration, Attention: Michael V. Owens, 300 River Place Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issues in this letter, please contact Mr. Owens at (313) 393-8100, extension 8167.

Sincerely,

/S/
Joann M. Givens
Detroit District Director
Detroit District Office

-

Sunrise Orchards Inc 2/23/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX; 313-393-8139

WARNING LETTER
2011-DET-05

February 23, 2011

VIA UPS

Thomas W. Kercher, President
Sunrise Orchards, Inc.
19498 County Road 38
Goshen, IN 46526-9135
 
Dear Mr. Kercher:

The U.S. Food & Drug Administration (FDA) inspected your juice processing facility, located at 19498 County Road 38, Goshen, IN 46526 on October 1, 4-5, 13, and 18-19, 2010. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120) and the Current Good Manufacturing Practices (CGMP) regulation for food (21 CFR Part 110). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120, or otherwise to operate in accordance with the requirements of Part 120, renders the juice 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 “100% Apple Cider” is  adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and guidance, and labeling regulations on FDA’s home page at www.fda.gov.

Your significant violations are as follows:

1.  You must maintain records documenting your HACCP system, as required by 21 CFR 120.12(a). However, your firm did not maintain monitoring records at the Culling Critical Control Point (CCP). According to your “Pasteurized Refrigerated Apple Juice” HACCP plan, your culling CCP lists the following critical limit:  “undamaged apples, <50 ppb patulin, >5 apples per 100 showing decay or moldy.” However, your firm does not record your culling activities which ensure that you only process undamaged apples. Your HACCP plan states that you will continuously monitor to ensure that “moldy, rotten, bruised or otherwise damaged fruit” will not be processed into juice; however, FDA’s inspection revealed that your firm used a bin of apples containing numerous damaged apples for production of  your 100% Apple Cider.

In addition, the FDA investigator noted seven days in 2009, and three in 2010, that you pressed apples for your 100% Apple Cider; but failed to maintain records demonstrating that you checked to ensure the metal screen was intact; per your “Pasteurized Refrigerated Apple Juice” HACCP plan’s “metal inclusion” CCP.

2. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with the conditions and practices specified in the CGMP regulation in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, our inspection showed that your firm did not monitor the following with sufficient frequency:

Condition and cleanliness of food contact surfaces, as evidenced by: Post-pasteurization piping is connected to the surge tank with duct tape. According to an employee, this piping is only cleaned using a water flush. In addition, the juice batch tank lid holes are closed with duct tape.

Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, as evidenced by:  Pasteurized apple juice was observed leaking from piping leading from the surge tank to the rotary filler and dripping on the outer surface of the rotary filler directly onto the bottle filling line. An opened, half-filled bottle of pasteurized juice was kept in an area adjacent to the jug wash spray, subjecting the bottle to spray mist of water that has hit the conveyor belt before the bottle was filled, capped, and boxed. There was a hole in the roof of the storage area where two torn bags of rice hulls were observed, exposing the rice hulls to the environment.

Proper labeling, storage and use of toxic compounds, as evidenced by: Unlabeled hand spray pumps of (b)(4) chemical sanitizer were stored adjacent to the apple wash tank.

Exclusion of pests, as evidenced by: Numerous fruit flies were observed on and around the surge tank, on piping leading to the makeup tank, on piping leading from the pasteurizer to the bulk storage tank, and piping from the surge tank to the rotary filler. At least two gaps were observed; one under the garage door and the other in the south wall. These gaps could allow entry of pests into the facility. In addition, a hole was observed in the roof of the storage area.

In addition, it is important that you not only monitor sanitation, but maintain monitoring records documenting your implementation of your Sanitation Standard Operating Procedures (SSOPs) to comply with 21 CFR 120.6(c).

3. You must hold foods that can support the rapid growth of undesirable microorganisms, in a manner that prevents the food from becoming adulterated, as required by 21 CFR 110.80(b)(3). 

However, you failed to maintain your 100% Apple Cider at refrigerated temperatures to prevent the rapid growth of undesirable bacteria. Our investigation revealed that your 100% Apple Cider was stored in an unrefrigerated storage tank for up to 7 days prior to bottling. Undesirable microorganisms, such as bacteria and molds, could possibly grow in your pasteurized apple cider under unrefrigerated conditions.

We acknowledge your written response to the FDA 483, List of Inspectional Observations, received on January 19, 2011; however, your response to the violations above was deemed inadequate because it lacked documentation of your corrections, such as monitoring records covering your implementation of your apple juice HACCP plan, processing sanitation, and the implementation of your SSOPs.

This letter does not list all of the violations observed at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, and FDA’s implementing regulations, including the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). 

You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

For your information, a FDA Guidance for Industry, titled “Juice HACCP Hazards and Controls,” that may be helpful to your firm is available on FDA's website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm.

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

Your reply should be sent to the Food and Drug Administration, Attention: CDR Kimberly Y. Martin, Compliance Officer, at the above address.  If you have questions regarding any issue in this letter, please contact Compliance Officer Martin (317) 226-6500 extension 116.

Sincerely,

/s/

Joann M. Givens
Detroit District Director
Detroit District Office
   

 

 

 

 

 

 

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