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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FAVPEP LLC 26-Apr-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


555 Winderley PI., Ste. 200
Maitland, Fl 32751




April 26, 2007

Miquel (nmi) Boutureira-Sanchez, President
D/b/a Queenmar LLC
7878 N.W. 46th Street
Miami, Florida 33166-5461

Dear Mr. Boutureira-Sanchez:

We inspected your seafood importer establishment, located at 7878 N.W. 46th Street on March 6-7,2007. 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 imported crabmeat products 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 was as follows:

1. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm performed an affirmative step of regularly inspecting the foreign processor's facilities for paste canned crabmeat manufactured by [redacted] that was not adequate. Specifically, you stated the foreign processor is inspected on a monthly basis. However, you had no such records of these inspections to ensure the crabmeat is processed in accordance with the regulation requirements.

We may take further action if you do not promptly correct this violation. 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 written response received on March 12, 2007 and receipt of documents sent to our Miami office on March 27, 2007. However, our review of the response and records finds that you failed to implement adequate corrections from our inspection. For example, your firm failed to provide any written verification procedures that list product specifications or the affirmative step that your firm will implement for ensuring the imported fish and fishery products were processed in accordance with these HACCP requirements. In addition, you provided an undated foreign processor inspection report that fails to include any assessment performed by a HACCP trained auditor including review of the firm's HACCP plan, monitoring records or sanitation control records. Our review of the provided HACCP plan for canned pasteurized crabmeat finds that it fails to declare the food safety hazards for most CCPs and appears to have either translation errors or deviations. In addition, no HACCP plan was provided for fresh ready-to-eat crabmeat that you import from the same processor. Therefore, you have failed to implement an appropriate affirmative step for these crabmeat products.

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 verification procedures, product specifications, 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, Attention: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.



Emma R. Singleton
Director, Florida District