Inspections, Compliance, Enforcement, and Criminal Investigations
Packers Provisions Co. of PR 02-Sep-08
Department of Health and Human Services
Public Health Service
San Juan District
September 2, 2008
Return Receipt Requested
Mr. Diego Suarez Matienzo
CEO and Director
Packers Provisions Co. of PR
P.O. Box 364588
San Juan, PR 00936-4588
Dear Mr. Suarez:
We inspected your seafood importer establishment, located at Building C, #1229, Mercado Central Puerto Nuevo, Puerto Rico 00920 on May 29-30, 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 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set forth in 21 CFR 123.12, Special requirements for imported products. As an importer of fish and 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 and fishery products have been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish and fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified recurrent serious violations from 21 CFR Part 123, your paella seafood, seafood mix, pollock fillets, kingfish, octopus, and imitation crab meat are adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), 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.
Your significant violation is as follow:
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). However your firm did not perform an affirmative step for the paella seafood and seafood mix that you import from [(b)(4)] the kingfish that you import from [(b)(4)] the dried salted pollock fillets that you import from [(b)(4)] and the crabmeat that you import from [(b)(4)].
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," seize your product(s) and/or enjoin 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 and records that document the performance and results of your firm's affirmative steps, 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9539 or firstname.lastname@example.org.
San Juan District