Inspections, Compliance, Enforcement, and Criminal Investigations
Blue Pacific Seafood, Inc. (DBA Shrimp Works, aka Water Works) 14-Jul-08
Department of Health and Human Services
Public Health Service
Southwest Import District
Via Fed EX
REF: WL FY08-SWID-001
Monday, July 14, 2008
Mr. Robert Eifert, Owner/Importer of Record
Blue Pacific Seafood, Inc. DBA Shrimp Works, aka Water Works
3371 National Ave
San Diego CA 92113
Dear Mr. Eifert:
We inspected your seafood importer establishment, located at 3371 National Avenue, San Diego, CA 92113 on March 5, 2008. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery product will appear to be adulterated under Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 381(a)(3) and will be denied entry. Because our inspection identified a serious violation of 21 CFR Part 123, your fresh yellowtail is adulterated under 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 it 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.
Your significant violation was as follows:
• You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for fresh yellowtail manufactured by [redacted] in Mexico.
We may take further action if you do not promptly correct these violations. 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," seizing your product(s) and/or enjoining your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Brian Ravitch, Compliance Officer, 2320 Paseo De Las Americas, Suite 200, San Diego CA 92154. If you have questions regarding any issues in this letter, please contact Brian Ravitch at (619) 661-2350 ext. 103.
Robert J. Deininger