Inspections, Compliance, Enforcement, and Criminal Investigations
T.H. Seafood 11-Jun-08
Department of Health and Human Services
Public Health Service
June 11, 2008
RETURN RECEIPT REQUESTED
In reply, refer to Warning Letter, SEA 08-21
Shin Nishimura, President
P.O Box 53141
Bellevue, Washington 98015
Dear Mr. Shin:
We inspected your seafood processing facility, located at 7901 2nd Avenue South, Seattle, Washington, on April 15-27, 2008. 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 Scombroid forming seafood and canned crabmeat products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. We acknowledge the receipt of a response from Cliff Davenport, Manager, on May 5, 2008.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's revised plan for canned crab meat~dated 0417-08 and submitted in response to the observations of concern listed-on the FDA Form 483 does not list monitoring procedures and frequencies at the receiving critical control point to control pathogen growth and potential toxin formation. Specifically, your plan lists "Receiving Iced", however, you do not include any monitoring procedures and/or monitoring frequencies associated with monitoring for the presence of ice at receiving.
2. Because you chose to include a corrective action in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR Part' 123.7(b). However, your corrective action plan for your crabmeat at the storage critical control point listed as "Recall product in compliance with recall notifications" is not appropriate. Your corrective action plan does not include what you will do with affected product still at your facility to ensure that none enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. You also don't identify how you will correct the cause of the deviation to prevent it from recurring.
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 prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. Soiled aprons hung in an area outside the processing room that would be used by employees working with ready-to-eat product. The aprons had dried encrusted material on them.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline.the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act; the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand,
Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issues in this letter,, please contact CO Elrand at (425) 4834913.
Charles M. Breen
cc: WSDA with disclosure statement