Inspections, Compliance, Enforcement, and Criminal Investigations
Carribean Conch, Inc. 05-Sep-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUEST
September 5, 2006
Janitise (nmi) Martinez, President
Caribbean Conch, Inc.
750 West 20th Street
Hialeah, FL 33010-2430
Dear Ms . Martinez:
We inspected your seafood importer and warehouse establishment, located at the above address on April 26-27, 2006. 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 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 a serious violation for 21 CFR Part 123, your frozen whelk meat, lobster tails and conch meat are 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 is as follows:
1. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm failed to perform affirmative steps for frozen whellk meat from [redacted]. Retrospectively, you provided a written guarantee from this foreign processor. However, copies of the firm's HACCP plan(s) in English have not been provided and no other affirmative step was implemented. This foreign processor is also not found on the list of establishments approved to export to the United States posted by the Canadian Food Inspection Agency.
In addition, the guarantee and HACCP plan for frozen lobster tails from foreign processor [redacted] hat you provided post-inspectionally are not in English.
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.
We acknowledge receipt of your response letter dated May 24, 2006 and supporting documentation. This letter addresses the continued deviations after review of your response letter. In addition, your firm has not developed product specifications for the fish and fishery products your firm imports. Your response letter also does not address any hazard analyses conducted concerning the fishery products in domestic commerce warehoused by your firm.
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 all these violations. You should include in your response documentation, such as 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.
Please send your reply to the Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Shari H. Shambaugh. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District