|Company:||Koike Seafood, Inc.|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||Seattle District Office|
|Issued:||Aug. 28, 2008||Closed:||
Department of Health and Human Services
Public Health Service
August 28, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-32
Paul J. Tourangeau, Owner
Koike Seafood, Inc.
500 South River Street
Seattle, Washington 98108
Dear Mr. Tourangeau:
We inspected your firm located at 500 South River Street on July 9-10, 2008. We found that you have 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 is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby they have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must implement the monitoring procedures and frequency that you have identified in your plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure listed in your HACCP plan for tuna, mahi-mahi, and marlin ono (also identified as HACCP Plan Form-Group 2) at the storage critical control point of monitoring cooler temperatures with a temperature logger continuously with a visual check once a day. Our investigator observed that you did not have a continuous temperature logger installed on your cooler.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your correction action plan for your tuna, mahi-mahi, and marlin Ono at the receiving critical control point is not appropriate because it does not ensure that adulterated product does not enter into commerce. Specifically, re-icing and/or bringing the temperature to below 40°F once the product has been temperature abused does not prevent, product that has already been abused during transit from entering into domestic commerce.
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) 483-4913.
Charles M. Breen
cc: WSDA with disclosure statement