www.online-smoke.com 7/29/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229

 

VIA Electronic Mail

 JUL 29, 2011

To:       buy21@live.com

            http://www.online-smoke.com

 

WARNING LETTER

 

The Food and Drug Administration (FDA) recently reviewed your website, http://www.online-smoke.com and determined that the cigarette products listed there are offered for sale to U.S. customers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

 

FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Kiss Fresh Apple Superslims cigarettes are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

 

You describe products that you offer for sale on your website as being light by referring to them as such in product advertising and adding the qualifiers “Light,” “Ultra Light,” “Super Light,” and “Extra Light” to the product names. Specifically, our review of your website revealed that you offer for sale products listed as “Chesterfield Classic Blue Lights,” “Chesterfield Classic Bronze Ultra Lights,” “Davidoff Gold Lights,” “Davidoff Gold Slims Lights 100’s,” “Dubliss Blue Lights,” “L&M Blue Lights,” “Pall Mall Azure Super Light,” “Parliament Acqua Blue Lights,” “Parliament Silver Blue Extra Lights,” “West Blue Ultra Lights,” “West Silver Lights,” and “Winston Super Slims Blue Lights 100’s.” 

 

A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).  Because your website uses the descriptor “Light” or similar descriptors for the above-listed products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

 

Additionally, our review of your website revealed that you offer for sale the following cigarettes: Kiss Fresh Apple Superslims, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:

 

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice…that is a characterizing flavor of the tobacco product or tobacco smoke.

 

As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.

 

If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain apple as a characterizing flavor of the tobacco products.

 

You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.

 

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products. 

 

Please direct your response to the following address:

 

PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850. 

 

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235.

 

 

Sincerely,
/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

 

 

VIA UPS and Electronic Mail

 

cc:

 

Domains by Proxy, Inc.

DomainsByProxy.com

15111 N. Hayden Rd., Ste 160, PMB 353

Scottsdale, Arizona 85260

online-smoke.com@domainsbyproxy.com

 

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Pharmaceutical Innovations, Inc. 7/29/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054

Telephone (973) 331-4906

July 29, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

11-NWJ- 21 

Mr. Gilbert Buchalter
President
Pharmaceutical Innovations, Inc.
897 Frelinghuysen Avenue
Newark, NJ 07114

Dear Mr. Buchalter:

During an inspection of your firm located in Newark, New Jersey,on April 14, 2011 through May 5, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufacturers Ultra Phonic Conductivity Gel, Sonic Generic Ultrasound Transmission Gel, Ultra Phonic Fontanelle Scanning Pad, and Ultra Phonic Focus Conforming Gel Pad. 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.

At the close of the inspection, FDA Investigators discussed with you objectionable conditions observed during the inspection. A Form FDA-483 was issued to you.

The FDA inspection revealed that your 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 that was dated June 10, 2011 concerning our investigator's observations noted on the Form FDA 483, List of addition, Inspectional Observations. 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 procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your Ultra Phonic Conductivity Gel, lot # 100110, was released to the market as a sterile product; however, your firm failed to establish and maintain documented procedures for final inspection and testing activities in order to verify that the specified sterility requirements for the Ultra Phonic Conductivity Gel were met.

We reviewed your response and conclude that it is not adequate, because there was no reference to any sterility testing being performed for Lot 100110, Ultra Phonic Conductivity Gel, prior to release. In addition, your response does not discuss the specific requirements for forming the basis of final inspection and test for your Ultra Phonic Conductivity Gel in order to verify all designated release characteristics were met for your device's intended use.

2. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72. Specifically, your firm has failed to ensure that your (b)(4) dryheat sterilizers were routinely calibrated, inspected, checked, and maintained prior to use. These dry heat sterilizers are used to sterilize your 20 ml Ultra Phonic Conductivity Gel which is sold by your firm as a sterile product.

We reviewed your response and conclude that it is not adequate because there is no indication that your (b)(4)  dryheat sterilizers are routinely calibrated, inspected, checked, and maintained prior to use. Your firm has failed to include provisions for remedial action in order to reestablish the limits and to evaluate whether there could be any adverse effect on your device's quality.

3. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 CFR 820.100(a)(3). Specifically, your firm failed to open a Corrective Action Preventive Action (CAPA) for Medical Device Report (MDR) complaint 742 that documents NICU babies with positive cultures for Pseudomonas. The hospital's investigation led to culturing your ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism. Your firm's investigation concluded that your product was improperly used without identifying the actions needed to prevent recurrence of a nonconformity or potential nonconformity.

We reviewed your response and conclude that it is not adequate because your firm's investigation concluded that your product was improperly used without your firm identifying any corrective or preventative actions to prevent recurrence of a nonconformity or potential nonconformity. In addition, there is no documentation included in your response concerning any failure analysis or laboratory testing of the ultrasound gel that was listed in the MDR report, including a complete description of the methodology used for the testing by the hospital and your contract laboratory. Furthermore, no laboratory test results were provided in your response confirming negative results for the Pseudomonas organism in your ultrasound gel product.

4. Failure to maintain Device Master Records (DMR's) as required by 21 CFR 820.181. Specifically, your firm's Device Master Record for the Ultra Phonic Fontanelle Scanning Pad fails to include, or refer to the location of, the following information: device specifications including appropriate drawings, composition, formulation, component specifications; production process specifications including production methods, production procedures, and production environment specifications; quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; packaging and labeling specifications, including methods and processes used.

We reviewed your response and concluded that it is not adequate because the DMR collected during the inspection for your Ultra Phonic Fontanelle Scanning Pad was not adequately maintained as per 21 CFR § 820.181. No documentation was included in your response to indicate that this violation was adequately corrected.

5. Failure to maintain Device History Records to ensure each batch, lot, or unit is maintained to demonstrate that the device is manufactured in accordance with DMR as required by 21 CFR 820.184. Specifically, the primary identification label and labeling used for each production unit was missing for your Ultra Phonic Conductivity Gel control # 021010 and 080810. This violation was documented during a previous inspection.

We reviewed your response and concluded that it is not adequate because there was no indication that you will be including any primary identification label and labeling with your Device History Records.

6. Failure to perform design validation under defined operating conditions on initial production units, lots, or batches to ensure that devices conform to defined user needs and intended uses as required by 21 CFR 820.30(g). Specifically, there was no design validation performed for your Ultra Phonic Fontanelle Scanning Pad in order to ensure that it conforms to defined user needs and intended uses. The product labeling indicates that the intended use of your Ultra Phonic Fontanell Scanning Pad is for the ultrasound of neonates on their skin and skull. Your firm has failed to perform testing of your finished devices for performance under actual conditions of use or simulated use conditions in the actual or simulated environment in which the device is expected to be used.

We reviewed your response and concluded that it is not adequate because your firm will not perform design validation for your Ultra Phonic Fontanelle Scanning Pad in order to ensure that it conforms to defined user needs and intended uses.

7. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure where the changes shall be verified or, where appropriate validated according to 21 CFR 820.75 as required by 21 CFR 820.70(b). Specifically, your batch record log for your Ultra Phonic Conductivity Gel 36-1000 documents different formulas were used for lots # 010101, 011201, and 041401. Your firm has failed to review and evaluate the process changes for your Ultra Phonic Conductivity Gel and perform revalidation where appropriate.

We reviewed your response and concluded that it is not adequate because no documentation was provided to show that you had verified the changes made to the formula did not influence the validated process for your Ultra Phonic Conductivity Gel.

8. 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, operating procedure QOP-4.10.4-1, Final Inspection and Testing, requires a nonconformity report to be prepared for nonconforming product in order to identify and correct reoccurring problems. Your firm failed to generate a nonconforming report for lot # 052610, Fontanelle Scanning Pads, where 24 units of finished product were rejected without an investigation into the root cause of the nonconformities.

We reviewed your response and concluded that it is not adequate because your firm has failed to implement procedure QOP-4.1 0.4-1 which requires a nonconformity report to be prepared for nonconforming product. In addition, your firm is required under 21 CFR 820.90(a) to evaluate a nonconformance that includes a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance, where the evaluation and the investigation would need to be documented.

9. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, your firm has no written agreements with the suppliers of raw materials and the laboratories used to do finished product testing, such as microbial testing of your sterile Ultra Phonic Conductivity Gel packets. In addition, your firm has failed to provide your testing facilities with any microbial testing requirements specific to your finished devices. Furthermore, your firm does not conduct any audits of your suppliers and laboratory testing facilities in order to ensure that all purchased or otherwise received product and services conform to your specified requirements.

We reviewed your response and concluded that it is not adequate because your firm has not provided any documentation to support that you have established and maintained procedures to ensure that all purchased or otherwise received product and services conform to your specified requirements. Purchasing must be carried out under adequate controls, including the assessment and selection of suppliers, contractors, and consultants in order to ensure that only acceptable products and services are received. The specifications for the finished device cannot be met unless the individual parts of the finished device meet specifications.

10. Failure to maintain legible records for review and copying at the manufacturing establishment or other location that is reasonably accessible to employees of FDA designated to perform inspections as required by 21 CFR 820.180. Specifically, all documents and procedures provided to employees of FDA for the manufacture of your Fontanelle Scanning Pads or the Ultra Phonic Conductivity Gel were written over with a black marking pen and were made illegible. These records contained the specifications and formulations for your Ultra Phonic Conductivity Gel.

We reviewed your response and concluded that it is not adequate because you cannot remove information from records that are required to be maintained by 21 CFR 820. This includes specifications and formulations for the manufacture of your Fontanelle Scanning Pads and Ultra Phonic Conductivity Gel.

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 FDA 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 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 action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) 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 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/

Diana Amador-Toro
District Director
New Jersey District Office
 

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Uttecht, Kenneth 7/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401

July 28, 2011 

 

WARNING LETTER

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED                          

Refer to MIN 11 – 40

 

 

Kenneth L. Uttecht

Co-owner

Uttecht Dairy Farm

N9127 Bluebird Road

Birnamwood, Wisconsin  54414

 

Dear Mr. Uttecht:

 

An investigation of your dairy operation at N9127 Bluebird Road, Birnamwood, Wisconsin, was conducted by a representative of the Food and Drug Administration (FDA) on May 23-25, 2011. That investigation confirmed that you offered animals for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii), and 402(a)(4), 21 U.S.C. § 342(a)(4), of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.

 

On or about December 6, 2010, you sold a veal calf identified with backtag number (b)(4) through (b)(4). On or about December 8, 2010, that animal was slaughtered for food at (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 neomycin at 14.91 ppm in kidney tissue. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.430, 21 CFR 556.430. The presence of this drug in this amount in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii).

 

On or about March 7, 2011, you sold a veal calf identified with backtag number (b)(4) through (b)(4). On or about March 9, 2011, that animal was slaughtered for food at (b)(4). USDA/FSIS analysis of tissue samples collected from that animal identified the presence of neomycin at 124.54 ppm in kidney tissue and penicillin at 0.07 ppm in kidney tissue. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 CFR 556.430. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 CFR 556.510. The presence of these drugs in these amounts in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii), 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you fail to maintain drug treatment records, you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals, and you lack a system for identifying animals that you transport and deliver for sale. 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).

 

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 above violations and to establish procedures whereby such 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 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 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 demonstrating that corrections have been made.

 

Your written response should be sent to Timothy G. Philips, Compliance Officer, at the address in this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.

 

Sincerely,

/S/

Gerald J. Berg

Director

Minneapolis District

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Close Out Letter

• Uttecht, Kenneth - Close Out Letter 10/12/11

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Timothy R. Nelson 7/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214·3340 Telephone: (913) 752-2100

July 28, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 WARNING LETTER

 

Ref. KAN 2011-13
 

Timothy R. Nelson, Cattle Dealer
2546 250th Street
Doon, Iowa 51235
 

Dear Mr. Nelson:
 

On March 10-11, and March 16, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 2546 250th Street, Doon, Iowa. This letter notifies you of the violations of the Federal Food, Drug, 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 FDA's web page at www.fda.gov.
 

We found that you offered for sale an animal 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].
 

Specifically, our investigation revealed on or about January 19, you sold a cow, identified with back tag number (b)(4) for slaughter as food. On or about January 19, 2011, (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 0.159 ppm of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm in the liver for residues of flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. § 556.286). The presence of this drug in edible tissues from this animal in these amounts causes the food to be unsafe within the meaning of 512 of the Act [21 U.S.C. § 360b], and adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. § 342(a)(2)(C)(ii)].
 

The above is not intended to be an all-inclusive list of violations. As a dealer 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.
 

Please send your response to Danial S. Hutchison, Compliance Officer, at the above address.
 

Sincerely yours,
/S/

John W. Thorsky
District Director
Kansas City District
 

cc:
Kevin E. Klommhaus, Bureau Chief
Feed & Fertilizer Bureau
Emergency Response
Iowa Department of Agriculture & Land Stewardship
502 E. 9111 Street
Wallace Building
Des Moines, IA 50319

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Pine Groves Farm Ltd. 7/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214-3340 Telephone: (913) 752·2100

July 28, 2011
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2011-12
 

Mr. Clifford J. Blom, Cattle Dealer
Pine Groves Farm
2552 Fig Avenue
Doon, Iowa 51235-8067
 

Dear Mr. Blom:
 

On March 10, and 16, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 2552 Fig Avenue, Doon, Iowa. This letter notifies you of the violations of the Federal Food, Drug, 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 FDA's web page at www.fda.gov.
 

We found that you offered for sale an animal 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].
 

Specifically, our investigation revealed that on or about January 19, you sold a cow, identified with back tag number (b)(4) for slaughter as food. On or about January 19, 2011, (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 0.159 ppm of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm in the liver for residues of flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. § 556.286). The presence of this drug in edible tissues from this animal in these amounts causes the food to be unsafe within the meaning of 512 of the Act [21 U.S.C. § 360b], and adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. § 342(a)(2)(C)(ii)].

The above is not intended to be an all-inclusive list of violations. As a dealer 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.
 

We acknowledge the receipt of a response to the FDA-483 which issued at the conclusion of our investigation. In this letter you proposed corrective actions. The effectiveness of your proposed corrective actions will be evaluated during a future inspection. You should notify this office in writing of any additional steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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.
 

Please send your response to Danial S. Hutchison, Compliance Officer, at the above address.
 

Sincerely yours,

/S/
John W. Thorsky
District Director
Kansas City District

cc:
Kevin E. Klommhaus, Bureau Chief
Feed & Fertilizer Bureau
Emergency Response
Iowa Department of Agriculture & Land Stewardship
502 E. 9th Street
Wallace Building
Des Moines, lA 50319

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Merex Inc 7/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	5100 Paint Branch Parkway College Park, MD 20740

WARNING LETTER
Case #10 200652

July 28, 2011

VIA OVERNIGHT MAIL

Mr. Jerry Nickerson
President
Merex Inc.
6436 Quinpool Road
Halifax, Canada

Dear Mr. Nickerson:

We inspected your seafood processing facility, located at 6436 Quinpool Road, Halifax, Canada on February 21-22, 2011. 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 salted fish are adulterated, in that they have been prepared, packed, or held under 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.

We acknowledge receipt of your written response dated March 7, 2011 to the FDA 483 issued to your firm on February 22, 2011; however, we conclude that your response is inadequate in that you did not include any additional documentation that would enable us to verify your corrections have been completed.

We note the following serious deviations:

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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). 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 does not have a HACCP plan for:

a. refrigerated, smoked herring to control the food safety hazards of histamine formation and pathogen growth and toxin formation
b. refrigerated dried salted cod, Pollock, hake, cusk, and ling fish to control the food safety hazards of undeclared allergens and pathogen growth and toxin formation, specifically Clostridum botulinum and Staphylococcus aureus.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor (I) prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; (2) protection of food, food packaging material, and food contact surfaces from adulteration with condensate and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

a) The cooler next to the processing room, the raw material storage cooler and finished product cooler had rusty fans with dirt build-up that were blowing over boxed and exposed product that was stored beneath
b) The metal shelving structure appeared to be flaking rust-like flakes throughout the structures that were supporting pallets of loosely covered raw material salted fish
c) The finished product cooler had a mold-like growth and rust marks on the ceiling. This cooler designated for finished product also had partial pallets of raw material stored inside.

For additional information regarding FDA's recommended controls for the hazards and controls discussed above, please refer to Chapters 7, 13, and 14 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA's web
site at:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/index.htm

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. You should include in your response 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 other useful information such as repair receipts, repair invoices, photos and monitoring records, that would assist us in
evaluating your corrections. If you cannot complete all corrections before the 30 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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the facility producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts. An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation [21 CFR Part 123] is Import Alert #16-120. This alert can be found on FDA's web site at:

http://www.fda.gov/ora/fiars/ora_import_ia16120.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Product Adulteration Branch, HFS-606, Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Standra Purnell via email at standra.pumell@fda.hhs.gov.

Sincerely,

/s/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

(b) (4)

-

HBB, LLC dba Baked World 7/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	5100 Paint Branch Parkway College Park, MD 20740

 

WARNING LETTER

 

JUL 28, 2011

 

 

Via UPS Overnight Delivery Service

 

 

Terry Harris

HBB, LLC dba Baked World

1837 Harbor Avenue

Memphis, TN 38113

 

Re: 157572

 

 

Dear Mr. Harris:

                                                                                                                       

The Food and Drug Administration (FDA) has reviewed the regulatory status of your product, “Lazy Larry” (formerly “Lazy Cakes”). Your “Lazy Larry” product is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170. You can find copies of the FDCA and these regulations through links on FDA’s home page at http://www.fda.gov.

 

Your “Lazy Larry” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)].  Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:

 

- the product is marketed alongside snack foods;

- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);

- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;

- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);

- the appearance and packaging of the product as a brownie.

 

As previously sold, your “Lazy Cakes” product additionally was represented for use as conventional food, for example, by the use of the words “cakes” in the product name and use of the word “brownie” in the statement of identity on the package label.

 

Any substance added to a conventional food, such as your “Lazy Larry” product must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction [see 21 CFR Part 181]. As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods. 

 

FDA’s regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

• Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.” Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.” Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.

• Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.” Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.” Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].

• Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).1

We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.  In assessing the GRAS status of melatonin for use in a conventional food such as “Lazy Larry,” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Lazy Larry” product does not satisfy the criteria for GRAS status under 21 CFR 170.30.

 

FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your brownie product. Therefore, melatonin added to a conventional food is a food additive under section 201(s) of the FDCA [21 U.S.C § 321(s)] and is subject to the provisions of section 409 of the FDCA [21 U.S.C. § 348]. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing.  Melatonin is not approved for use in any food, including brownies. Therefore, your “Lazy Larry” product is adulterated within the meaning of section 402(a)(2)(C) of the FDCA [21 U.S.C. § 342(a)(2)(C)].

 

You should take prompt action to correct this violation and prevent its future recurrence. Failure to do so may result in enforcement action without further notice. The FDCA authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. We want you to be aware that FDA did not conduct an all-inclusive review of your “Lazy Larry” product or other products you manufacture or distribute. It is the responsibility of a manufacturer to ensure that foods the firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.

 

Please advise this office in writing within fifteen (15) days from your receipt of this letter as to the specific steps you have taken to correct the violation noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented. 

 

Please send your reply to Kathleen M. Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740.

 

 

Sincerely,

/S/ 

Michael W Roosevelt

Acting Director

Office of Compliance

Center for Food Safety

and Applied Nutrition

 

 

                                                                                                                                   

cc: New Orleans District Office

 

References:

1. Peschke, E., Schucht, H., and Muhlbauer, E. 2010. Long-term enteral administration of melatonin reduces plasma insulin and increases expression of pineal insulin receptors in both Wistar and type 2-diabetic Goto-Kakizaki rats. J. Pineal Res.; 49: 373-381.
2. Puchalski, S. S., Green, J. N., and Rasmussen, D. D. 2003. Melatonin effects on metabolism independent of gonad function. Endocrine; 21: 169-173.
3. Rasmussen, D. D., Boldt, B. M., Wilkinson, C. W., Yellon, S. M., and Matsumoto, A. M. 1999. Daily melatonin administration at middle age suppresses male rat visceral fat, plasma leptin, and plasma insulin to youthful levels. Endocrinology; 140: 10091012.
4. Cagnacci, A., Arangino, S., Renzi, A., Paoletti, A. M., Melis, G. B., Cagnacci, P., and Volpe, A. 2001. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clin Endocrinol. (Oxt); 54: 339-346.
5. Singh, H. J., Keah, L. S., Kumar, A., and Sirajudeen, K. N. S. 2011. Adverse effects of melatoninon rat pups of Wistar-Kyoto dams receiving melatonin supplementation during pregnancy. Exp. Toxicol. Pathol.; doi:10.1016j.etp.2011.01.011
6. Okatani, Y., Wakatsuki, A., Otukonyong, E. E., and Miyahara, Y. 2001. Effect of prenatal melatonin exposure on gonadotropins and prolactin secretion in male and female rat pups. Eur. J. Pharmacol.; 424: 229-235.
7. Luboshitzky, R., Shen-Orr, Z., Nave, R., Lavi, S., and Lavie, P. 2002. Melatonin administration alters semen quality in healthy men. J. Andrology ; 23: 572-578.
8. Woo, M. M. M., Tai, C. J., Kang, S. K., Nathwani, P. M., Pang, S. F., and Leung, P. C. K. 2001. Direct action of melatonin in human granulosa-luteal cells. J. Clin. Endocrinol & Metab.; 86: 4789--4797.
9. Okatani, Y, Okamoto, K., Hayashi, K., Wakatsuki, A., Tamura, S., and Sagara, Y. 1998. Maternal-fetal transfer of melatonin in pregnant women near term. J. Pineal Res.; 25:129-134.
10. Cagnacci, A., Soldani, R., and Yen, S. S. C. 1995. Exogenous melatonin enhances luteinizing hormone levels ofwomen in the follicular but not in the luteal menstrual phase. Fertil. Steril.; 63: 996-999.
11. Cagnacci, A., Paoletti, A.M., Soldani, R., Orm, M., Maschio, E., and Melis, G. B. 1995. Melatonin enhances the luteinizing hormone and follicle-stimulating hormone responses to gonadotropin-releasing hormone in the follicular, but not in the luteal, menstrual phase. J. Clin. Endocrinol. & Metab.; 80: 1095-1099.
12. Tailleux, A., Torpier, G., Bonnefont-Rousselot, D., Lestavel, S., Lemdani, M., Caudeville, B., Furman, C., Foricher, R., Gardes-Albert, M., Lesieur, D., Rolando, C., Teissier, E., Fruchart, J. C., Clavey, V., Fievet, C., and Duriez, P. 2002. Daily melatonin supplementation in mice increases atherosclerosis in proximal aorta. Biochem. Biophys. Res. Commun.; 293: 1114-1123.
13. Cook, J. S., Sauder, C. L., and Ray, C. A. 2011. Melatonin differentially affects vascular blood flow in humans. Am. J. Physiol. Heart Circ. Physiol.; 300: H670H674.
14. Nishiyama, K., Yasue, H., Moriyama, Y., Tsunoda, R., Ogawa, H., Yoshimura, M., and Kugiyama, K. 2001. Acute effects of melatonin administration on cardiovascular autonomic regulation in healthy men. Am. Heart J.; 141:E9.
15. Kitajima, T., Kanbayashi, T., Saitoh, Y., Ogawa, Y, Sugiyama, T., Kaneko, Y, Sasaki, Y., Aizawa, R., and Shimisu, T. 2001. The effects of oral melatonin on the autonomic function in healthy subjects. Psychiatry and Clin. Neurosci.; 55: 299-300.
16. Arangino, S., Cagnacci, A., Angiolucci, M., Vacca, A. M., Longu, G., Volpe, A., and Melis, G. B. 1999. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. Amer. J. Cardiol.; 83: 1417-1419.
17. Cagnacci, A., Arangino, S., Angiolucci, M., Maschio, E., and Melis, G. B. 1998. Influences of melatonin administration on the circulation of women. Amer. J. Physiol.; 274: R335-R338.
18. Wakatsuki, A., Okatani, Y., Ikenoue, N., Kaneda, C., and Fukaya, T. 2001. Effects of short-term melatonin administration on lipoprotein metabolism in normolipidemic postmenopausal women. Maturitas; 38: 171-177.
19. Wiechmann, A. F., Chignell, C. F., and Roberts, J. E. 2008. Influence of dietary melatonin on photoreceptor survival in the rat retina: An ocular toxicity study. Exp. Eye Res.; 86: 241-250.
20. Gagne, A. M., Danilenko, K. V., Rosolen, S. G., and Hebert, M. 2009. Impact of oral melatonin on the electroretinogram cone response. J. Circadian Rhythms; 7: 1421.
21. Rufiange, M., Dumont, M., and Lachapelle, P. 2002. Correlating retinal function with melatonin secretion in subjects with an early or late circadian phase. Investigative Ophthalmology & Visual Science; 43: 2491-2499.
22. Sheldon, S. H. 1998. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet; 351: 1254.
23. Whittom, S., M. Dumont, M., Petit, D., Desautels, A, Adama, B., Lavigne, G., and Montplaisir, J. 2010. Effects of melatonin and bright light administration on motor and sensory symptoms of RLS. Sleep Medicine; 11: 351-355.
 

---

1 Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients, Redbook 2000, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/default.htm.

-

La Villa Tortilleria, Inc. 7/27/11

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) 366-7801 FAX:  (615) 366-7802

July 27, 2011

WARNING LETTER NO. 2011-NOL-19

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Berenice E. Lopez, President
La Villa Tortilleria, Inc.
1223 Columbia Avenue
Franklin, Tennessee 37064-3618

Dear Ms. Lopez:

On April 20 and 22, 2011, a U. S. Food and Drug Administration (FDA) investigator inspected your corn tortilla manufacturing facility, located at 1223 Columbia Avenue, Franklin, Tennessee. The inspection found significant violations of FDA’s Current Good Manufacturing Practice requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause your corn tortilla products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 342(a)(4)], because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. At the conclusion of the inspection, the FDA investigator issued a Form FDA 483, Inspectional Observations, to Rosa E. Lopez, Co-Owner and Secretary.  You may find the Act and FDA’s regulations through links in FDA's Internet home page at www.fda.gov.

Your significant violations were as follows:

1. Your firm failed to take all reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging material conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. This includes washing hands thoroughly (and sanitizing, if necessary, to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically, our investigator observed:

• Two employees, on eight separate occasions, handling raw tortilla dough and then handling finished tortillas, during processing operations, without first washing their hands;
• Three employees, on five separate occasions, picking up discarded tortillas from the floor and then handling finished ready-to-eat (RTE) tortillas without first washing their hands;
• One employee touching the front of his visibly soiled pants and then handling RTE tortillas without first washing his hands;
• One employee adjusting the control knob on the raw tortilla former and then packaging RTE tortillas without first washing his hands; and,
• Two employees, on three separate occasions, returning to the production room from your firm’s retail kitchen and resuming work, including handling RTE tortillas, without first washing their hands.

2. Your firm failed to maintain buildings, fixtures and other physical facilities in a sanitary condition to prevent food from being contaminated, and failed to conduct cleaning and sanitizing of equipment in a manner which protects against contamination of food and food-contact surfaces, as required by 21 CFR 110.35(a). Specifically, our investigator observed on April 20, 2011, after processing operations had ended, an electric leaf blower was used to clean the floor of the production room and the tortilla conveyors, by blowing off the remaining dried product from the conveyors. This blew debris from the floor and the conveyors into the air around processing equipment. 

3. Your firm failed to properly maintain plant equipment and to use equipment so as to preclude the adulteration of food with any contaminants, as required by, 21 CFR 110.40(a). Specifically, our investigator observed:

• The guide used to control the fall of tortillas as they exited the oven conveyor onto the cooling conveyor was made of a plastic material which was torn and visibly stained.
• Paper towels were used in place of rubber gasket material in multiple components of the tortilla forming machine and in direct contact with raw tortilla dough during processing operations. Furthermore, prior to placement in the tortilla forming machine, the paper towels were dipped in a sanitizing solution observed to have a chlorine concentration above 200 ppm, which could cause the residue to become a food contaminant.

4. Your firm failed to use sanitizing agents on food-contact surfaces under safe conditions of use, as required by 21 CFR 110.35(d)(5).  Specifically, on April 20, 2011, our investigator observed on three occasions your employees diluted chlorinated bleach with water without measuring the amount of each component used and without testing the chlorine concentration levels of the sanitizing agent before use. This diluted chlorinated bleach was used on the tortilla dough table and tortilla former components, which contact the raw tortilla dough, and was used to wipe down the stacking and packing tables, which contact RTE tortillas prior to packaging. Our investigator observed the diluted chlorinated bleach had a chlorine concentration above 200 ppm on all three occasions, which could cause the residue to become a food contaminant. 

5. Your firm failed to provide adequate screening or otherwise protect against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed the bottom of the screen on the back door of the production room was torn. This door opens to the outside of the firm.

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 the Act and its implementing regulations.  You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including, but not limited to, seizure and/or injunction.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations and to prevent recurrence.  Your response should include any documentation necessary to show correction has been achieved.  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.

Please send your reply to the U.S. Food and Drug Administration, Attention: Cynthia R. Gibson, Compliance Officer, at the above address.  If you have questions regarding any issues in this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.

Sincerely,

/s/

Monica Maxwell
Acting District Director
New Orleans District

 

-

Gulf Medical Fiberoptics, Inc. 7/27/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751   Telephone: 407-475-4700         FAX: 407-475-4770

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

WARNING LETTER

FLA-11-34

 

July 27, 2011

 

Patrick R. Bennetts

President

Gulf Medical Fiberoptics, Inc.

448 Commerce Blvd

Oldsmar, FL 34677

 

Dear Mr. Bennetts:

 

During an inspection of your firm located in Oldsmar, Florida on April 27, 2011 through May 3, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures endoscopic fiber optic cables and Visualux™ surgical headlights. 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 Mr. Craig S. Vogeley, Vice President Operations, dated May 23, 2011, 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 that include the requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, you did not implement Section 5.6 of your Complaint/Corrective Action procedure, P-852, Rev C, which requires proposed corrective action to be verified or validated prior to implementation. You changed the dimensional specifications for one of the connectors, Drawing #1000043, used as a component of your Endoscopic Cable device, which was proposed under Corrective Action #32; however, your records do not demonstrate this proposed specification change was verified or validated prior to implementation.

We reviewed your response and conclude that it is not adequate because your firm did not conduct or document the verification for corrective action # 32 that was specific to dimension changes to the (b)(4) connector. Your firm has been aware of this issue since the initiation of this corrective action on July 19, 2010. Your firm’s previous response dated October 5, 2010, to the FDA 483 issued to your firm on September 17, 2010, stated that all of the required information would be added to this corrective action no later than October 29, 2010. 

2.      Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:

1. Your validation study for your process to manufacture optical fibers, conducted under Fiber Optic Drawing Tower Validation Master Plan, F-750-009, Rev A, did not include complete analysis of the Furnace Temperature process variable in order to demonstrate the effect it may have on finished product quality. The OQ portion of the protocol did not analyze temperatures above 1800°F, and records covering the PQ portion of the protocol did not demonstrate inclusion of operating temperatures above 1804°F, although your listed 1810 - 1775°F as the acceptable range for the Furnace Temperature processing variable.
2. Your records covering validation of your process to manufacture optical fibers, conducted under Fiber Optic Drawing Tower Validation Master Plan, F-750-009, Rev A, do not include identification of the instruments used to measure the Furnace Temperature and Take-Up Wheel Speed process variables and, thus, do not demonstrate these measuring devices were calibrated at the time of their use in the study.
3. You have not validated the cleaning process for your Visualux brand surgical headlight device, listed in the Instructions For Use that you distribute with the device, in order to demonstrate the cleaning process is consistently effective.

The adequacy of your response cannot be determined at this time. Your firm did not include documentation or evidence of the corrections and corrective actions specific to the cleaning validation for the surgical headlights. However, your firm provided adequate validation documentation for the furnace temperature and calibration data specific to the tachometer and thermometer. Additionally, this was a repeated deficiency from your previous FDA inspection of September 9 - 17, 2010.

 

3.      Failure to establish and maintain adequate procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example, you did not re-evaluate the Failure Modes and Effects Analysis (FMEA) for the Endoscopic Cable device as part of Corrective Action #32, and your record of the previous FMEA for this device listed a maximum likelihood for detecting a failure mode resulting from incorrect dimensions being selected during the design process.

 

The adequacy of your response cannot be determined at this time. Your firm did not include documentation or evidence of the corrections, corrective actions, or evidence of implementation specific to the updated Failure Mode and Effects Analysis for the Endoscopic Cable and Corrective Action procedure P-852 to ensure corrective action findings require a re-evaluation of the failure mode and risk. Additionally, this was a repeated deficiency from your previous FDA inspection of September 9 - 17, 2010.

 

4.      Failure to document acceptance activities, as required by 21 CFR 820.80(e). For example, you do not document the results of final acceptance testing covering connector fit testing for your Endoscopic Cable device.

 

We reviewed your response and conclude that it is not adequate. Your firm’s current F-750-010 Final Inspection form, Revision D, did not have a designated area to document the end tip final polish length. Additionally, your firm did not provide evidence of implementation for the Work Instruction WI-750-028 Fiber Optic Cable In Process and Final Inspection. Additionally, this was a repeated deficiency from your previous FDA inspection of September 9 - 17, 2010.

 

5.      Failure to establish and maintain adequate requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example:

1. Your Supplier Evaluation Form, F-740-002-A, referenced for use under Section 4.2.4 of your Purchasing procedure, P-740, Rev D, does not ensure vendors are evaluated based on criteria demonstrating their ability to meet quality requirements.
2. You did not implement Section 4.2 of your Purchasing procedure, P-740, Rev D, covering procedures to evaluate and select the contract servicer (b)(4) and laboratory (b)(4) used to execute the validation study covering the cleaning process listed in the Instructions for Use for your Visualux Fiber Optic Headlight.

We reviewed your response and conclude that it is not adequate. Your firm did not provide any evidence that they qualified their contract servicer (b)(4).  Additionally, your firm did not provide evidence of implementation for the revised Purchasing Procedure P-740 or the proposed draft version for the Supplier Evaluation Form F-740-002.  

 

6.      Failure to maintain adequate device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820. The DHR shall include, or refer to the location of, the primary identification label and labeling used for each production unit, as required by 21 CFR 820.184(e). For example, the DHRs covering production of your Endoscopic Cable devices for March 11 - 15, 2011, and April 8 - 26, 2011, did not include or reference all labels applied to the devices such as:

1. The stick-on label applied to the device identifying the responsible firm information was not included or referenced in 7 of 55 records reviewed.
2. None of the records reviewed included or referenced the sterilization label.

The adequacy of your response cannot be determined at this time. Your firm stated they will open a corrective action to determine why the DHRs were missing the responsible firm’s label. Additionally, your firm did not include documentation or evidence of implementation specific to the revised F-750-010 Final Cable Inspection Form and Work Instruction WI-750-028. 

 

7.      Failure to maintain adequate device master records (DMR's), as required by 21 CFR 820.181. For example, the Device Master Record for the Endoscopic Cable device did not include or refer to the location of the following manufacturing and quality acceptance procedures utilized by your production employees to manufacture your Endoscopic Cable device:

1. Fiber Bundle Acceptance, WI-750-014
2. Low Temperature Epoxy Application, WI-750-012
3. High Temperature Epoxy Application, WI-750-001-013

The adequacy of your response cannot be determined at this time. Your firm did not include documentation or evidence of the corrections, corrective actions, or evidence of implementation specific to the proposed Endoscopic Cable device master record revision.

 

8.      Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example:

1. Unapproved, electronic quality system documents are available for use by your department managers.
2. Section 5.3.1 of your Document Control procedure, P-423, Rev D, requires only the hard-copy signature of your Quality System Management Representative to demonstrate approval of a document, although the procedure also requires your department managers to approve documents used in their area of responsibility.
3. You have not implemented Section 5.3.1(b) of your Document Control procedure which requires you maintain a Master Document List, F-423-001, listing all approved quality documents.

Your response to this observation appears to be adequate. However, this was a repeated deficiency from your previous FDA inspection of September 9 - 17, 2010.

 

9.      Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s), as required by 21 CFR 820.30(c). For example, your Design Plan for Endoscopic Cables, F-730-001-A, dated March 2, 2002, did not list all appropriate design input requirements, including:

 

A.     Light transmission performance requirements.

 

B.     Dimensional requirements for optical fiber components.

 

C.     Dimensional requirements to ensure compatibility with standard connectors.

 

D.     Capability to withstand/prevent physical stress.

 

Your response to this observation appears to be adequate.

 

10. Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited, as required by 21 CFR 820.22.  For example:

1. You did not implement Section 5.2 of your Internal Audits procedure, P-822, Rev B, which requires the initiation of the internal audit based on the master schedule, in that you began internal audit procedures on June 22, 2010, although the Internal Audit Plan, F-822-001, for this audit was not created until June 23, 2010. Further, the record for this audit plan was not approved by the Quality System Management Representative as required under Section 5.1 of the procedure.
2. Your Internal Audits procedure, P-822, Rev B, does not require a report of the results of each quality audit be reviewed by the management responsible for the matters audited, and your records do not demonstrate such reviews have taken place.

Your response to this observation appears to be adequate.

 

A follow up inspection will be required to assure that corrections and/or corrective actions are adequate. 

 

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 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 fifteen 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.

 

Your response should be sent to Andrea H. Norwood, Compliance Officer at 555 Winderley Place, Suite 200, Maitland, FL 32751. Refer to the Unique Identification Number (CMS case # 195372) when replying. If you have any questions about the content of this letter please contact: Ms. Norwood at (407) 475-4724 or by facsimile (407) 475-4768. 

 

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 violation(s) 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 violations, and take prompt actions to correct the violations and to bring your products into compliance. 

 

Sincerely,

/S/

Edwin Ramos

Acting Director, Florida District

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Diana Fruit Company Incorporated 7/27/11

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

July 27, 2011

VIA UPS

Gene Acronico, President and CEO
Diana Fruit Company, Inc.
651 Mathew St
Santa Clara, CA 95050

WARNING LETTER

Dear Mr. Acronico:

The Food and Drug Administration (FDA) conducted an inspection of your acidified canned food manufacturing facility, located at 651 Mathew St, Santa Clara, CA 95050, from June 15, 2011 through June 23, 2011. The inspection determined that your facility produced acidified canned food products and revealed that you have significant deviations from the Emergency Permit Control regulations, and Acidified Foods regulations (21 CFR Parts 108, 21 CFR 114). 

As a manufacturer of acidified canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified canned food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control  [21 U.S.C. § 344].  A temporary emergency permit may be required for low-acid canned foods and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114 and 21 CFR Part 113.  In addition, based upon certain criteria in 21 CFR 114 and 21 CFR 113, acidified and low acid foods may be adulterated within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. 

During the inspection, our investigators documented deviations from the Act and the above mentioned regulations relating to the processing of Maraschino cherries. The deviations cause your acidified food products to be adulterated and in violation of the Section 402(a)(4) of the Act, in that your Maraschino cherries have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations on the Internet through links on the FDA’s home page at http://www.fda.gov.

The significant violations we found at your acidified food processing facility are as follows:

1. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).  Specifically, your firm has failed to file a scheduled process for each of the Maraschino cherry products that you manufacture. 

Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic).  More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at:  http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.

In addition, your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form FDA 2541 with the FDA, as required by 21 CFR 108.25(c)(1).

For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link:  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.

2. Your firm failed to exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm does not monitor or record the finished equilibrium pH of the Maraschino cherry products you manufacture to ensure that the finished equilibrium pH does not exceed 4.6.

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 systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.

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.

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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