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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shells & Fish Import and Export Co. 27-Oct-06

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

Public Health Service
Food and Drug Administration

 

Washington, DC


WARNING LETTER

October 27, 3006

Mr. Manuel X. Ramirez
Manager
Shells & Fish Import and Export Co.
2636 NW 97th Ave.
Miami, FL 33172

Dear Mr. Ramirez:

We inspected your seafood importer establishment, located at 2686 NW 97th Ave., Miami, Florida on June 27, 2006. 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 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 serious violations for 21 CFR Part 123, your shrimp 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.

The importer shall maintain records, in English, that document the performance and results of the affirmatives steps specified in 21 CFR 123.12(a)(2)(ii) to comply with 21 CFR 123.12(c). However, your response dated July 10, 2006 indicated that you had received "a) product specification that are designed to ensure that the product offered for import into the United States is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and/or b) on file a copy, in English, of the foreign processor's HACCP Plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with our requirements." The regulations specify that both affirmative steps and specifications are required. Please provide us with a copy documenting your verification procedures.

The above identified deviations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.

You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported seafood products without examination. Under such conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.

Please notify this office in writing within fifteen (l5) working days of receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made (e.g., copies of your product specifications, HACCP plans and written guarantees from the foreign suppliers). If corrections cannot be completed with 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

Your reply relating to these concerns should be directed to:

Food and Drug Administration,
Attention: Crystal McKenna
Import Branch HFS-606
Division of Enforcement, Office of Compliance
5100 Paint Branch Parkway
College Park, MD 20740

If you have questions regarding the implementation of the HACCP Regulations, you may contact Crystal McKenna at crystal.mekenna@fda.hhs.gov for answers and/or direction towards guidance and sources of training in achieving compliance.

We look forward to working with you to achieve a successful HACCP program.

Signature

/S/

Crystal McKenna
Consumer Safety Officer
Imports Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition