Inspections, Compliance, Enforcement, and Criminal Investigations
Crystal Bay Seafoods, Inc. 3/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
March 22, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12- 29
Jeffery J. England
President and Co-owner
Crystal Bay Seafoods, Inc.
808 Packerland Drive
Green Bay, Wisconsin 54303
Dear Mr. England:
We inspected your seafood processing facility located at 808 Packerland Drive, Green Bay, Wisconsin, on February 16-17, 2012. 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 and 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 Albacore Tuna, Wahoo, Bluefin Tuna, Escolar, Amberjack, Mahi Mahi, Herring fillets in wine sauce, creamed Herring fillets, vacuum-packed imitation Crab meat (surimi), and pasteurized canned Blue Swimming Crab Meat 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 on FDA's home page at www.fda.gov.
Your significant violation is as follows:
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). However, your firm does not have a HACCP plan for Albacore Tuna, Wahoo, Bluefin Tuna, Escolar, Amberjack, Mahi Mahi, Herring fillets in wine sauce, and creamed Herring fillets products to control the food safety hazards of histamine formation. Also, your firm does not have a HACCP plan for vacuum-packed imitation Crab meat (surimi) and pasteurized canned Blue Swimming Crab Meat to control the hazard of Clostridium botulinum growth and toxin formation. Furthermore, your temperature monitoring procedures for product receiving and storage are not conducted with a frequency that will control the formation of histamine and Clostridium botulinum growth and toxin formation during transit and during storage.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your products and/ or enjoin your firm from operating.
Please note that FDA has recently published a 4th edition of the "Fish and Fisheries Products Hazards and Controls Guidance." This new publication provides the most current information to assist processors in developing their HACCP plans. For specific information on the hazard of Clostridium botulinum toxin formation, please refer to Chapter 13.
Also, you are required to monitor sanitation conditions and practices during processing, which includes warehousing activities, with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b).
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct this violation. 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 123) and the Current 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 the Food and Drug Administration, Attention: Rebecca L. Caulfield, Compliance Officer, at the address on this letter. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
Elizabeth A. Waltrip