Inspections, Compliance, Enforcement, and Criminal Investigations
Tonka Seafoods, Inc. 11/10/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
November 10, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-05
Wendel E. Gilbert, President
Tonka Seafoods, Inc.
P.O. Box 1420
Petersburg, Alaska 99833
Dear Mr. Gilbert:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing and low-acid food manufacturing facility located at 22 Sing Lee Alley, Petersburg, Alaska, on August 15-17, 2011. During the inspection, our investigators observed serious violations of the Domestic Low-Acid Canned Food (LACF) regulation, Title 21, Code of Federal Regulations, Parts 113 (21 CFR 113) and the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR 123. As a manufacturer of low-acid 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 low-acid food products. These regulations are described in 21 CFR 108, Emergency Permit Control and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. Failure to comply with all the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provision of Section 404 of the Act [21 United States Code (U.S.C.) § 344].
The inspection revealed that your smoked pink and sockeye salmon thermally processed in hermetically sealed retort pouches, a low-acid seafood product, are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act, the LACF regulation, and the seafood HACCP regulation through links in the FDA’s homepage at http://www.fda.gov.
The significant violations include, but are not limited to, the following:
1. Failure to record appropriate detailed inspections and tests of container closures other than double seams and glass containers at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production as required by 21 CFR 113.60(a)(3). Specifically, you did not record visual retort pouch closure examination during processing of your smoked pink salmon in retort pouches lot AC42811X on March 27-28, 2011, and your smoked sockeye salmon in retort pouches lot AC92731X on March 31, 2011, and lot AC92671X on April 8, 2011.
Furthermore, performing one burst test and one residual air test of one batch of low-acid food is not sufficient to detect pouches with leaking seals or weak seals that have potential to leak. For example, you performed one burst test and one residual air test on one 16 oz pouch of (b)(4) pouches for lot AC42811X that was thermally processed in (b)(4) retort loads on March 27-28, 2011.
2. Failure to observe, record, and complete any corrective actions necessary when gross closure defects are observed during production as required by 21 CFR 113.60(a). Specifically, on August 16, 2011, we observed approximately 40 pouches out of (b)(4) pouches were removed for leakage during an overnight culling and sorting of the product. Further, there was no documentation of this event and an investigation was not performed to determine the cause or potential source of the leaking containers.
3. 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 the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
A) Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]
i) On August 15-16, 2011, a cutting board, used to portion cut the salmon before filling (b)(4) metal cans, was observed by our investigator to contain a heavy yellow residue build up on the food contact surface.
ii) On August 15, 2011, a large white tub, used to hold smoked salmon fillets, contained dark residue in the deep grooves while in direct contact with the smoked pink salmon fillets.
iii) On August 19, 2011, yellow tubs, used to hold the unsealed pouches of smoked pink salmon fillets, contained dark residue on the sides of the containers. Employees were observed handling the side of the containers while filling the pouches.
iv) On August 15-16, 2011, smokehouse rack screens were observed to contain a heavy dark fish residue on the screens. The screens are not cleaned or rinsed before being reused to place brined pink salmon fillets into the smokehouse.
B) Prevention of cross-contamination [21 CFR 123.11(b)(3)]
i) On August 15-16, 2011, our investigator observed at least three of your employees on each day conduct multiple tasks without washing their hands or changing gloves between tasks. For example, your employee resumed handling pink salmon fillets after handling the bottom of a plastic trash can, dumping fish waste into a tote, and then removing the trash can from the production area.
ii) On August 15-16, 2011, our investigator observed at least five employees involved with filleting, trimming, packing, and handling pink salmon and ready to eat smoked salmon fillets with bare arms. The employees’ arms were in contact with the food contact surface of the salmon storage containers and smokehouse rack screens.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
In addition, we are concerned with your firm’s practice of processing low-acid foods in retort pouches coded with the previous week’s lot code prior to using retort pouches with the current week’s lot code. This practice could potentially lead to an ineffective recall of products with public health significance in a timely manner. We strongly encourage you to discontinue this practice.
You should respond in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. You should also include in your response any documentation 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.
Please send your response to the U.S. Food and Drug Administration, Seattle District, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Peter C. Chow, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Chow at (425) 483-4766.
Charles M. Breen