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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seven Seas Seafoods Inc. 10/27/11


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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900



W/L: 04-12

October 27, 2011

Mr. Chris Lin, President
Seven Seas Seafoods Inc.
1150 S. Vail Avenue
Montebello, CA 90640-6021

Dear Mr. Lin:

The US Food and Drug Administration (FDA) inspected your seafood importer establishment, located at 1150 S. Vail Avenue, Montebello, CA 90640-6021 on September 1st through September 6th, 2011. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

Specifically, your firm was cited for the following violations:

• Failure to have or implement an affirmative step which ensures that the frozen tuna manufactured by (b)(4) and imported by your firm is processed in accordance with the seafood HACCP regulation pursuant to 21 CFR 123.12(a)(2)(ii).

• Failure to have product specifications that are designed to ensure that the frozen tuna manufactured by (b)(4) and imported by your firm is not injurious to health in accordance with 21 CFR 123.12(a)(2)(i).

As an importer of fish or fishery products, you must operate in accordance with the requirements specified in 21 CFR 123.12. Pursuant to 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. Seafood products offered for entry without such evidence 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 maybe denied entry into US commerce.

The above mentioned frozen tuna products imported by your firm are in violation of 21 CFR Part 123 and are thus considered 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. We may detain future entries of these seafood products imported or offered for import by your firm pursuant to section 801(a) of the Act (21 U.S.C. § 381(a)) and list those products on Import Alert 16-119, which will advise all FDA district offices to detain the products without physical exam.

Furthermore, FDA may take additional regulatory action against your firm if you do not promptly correct the violations cited in this letter. For example, we may broaden Import Alert 16-119 to advise FDA district offices to detain without physical exam any seafood products imported by your firm. Other regulatory action may include enjoining your firm to prevent future violations of the Act and seizure of your firm's merchandise found to be in violation of the Act.

Please note that 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 all applicable laws and regulations including the seafood HACCP regulation (21 CFR Part 123).

For assistance in meeting these requirements, you may consult FDA's website at www.fda.gov which provides links to reference documents including postings of the seafood HACCP regulation, the Federal Food, Drug, and Cosmetic Act, and the Fish and Fisheries Products Hazards & Controls Guidance.

You should respond to this letter in writing within fifteen (15) working days from the date you receive this letter. Your response should outline the specific steps you are taking to correct the violations cited in this letter. This response should include the HACCP documentation or importer verification records including 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 of these corrections within fifteen (15) working days from the date you receive this letter, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to:

Food and Drug Administration
Attention: Daniel Solis
Director, Import Operations Branch
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731

If you have any questions regarding this letter, please contact Carla Fernandez Borges, Compliance Officer, at (310) 971-2373.



Alonza E. Cruse, Director
Los Angeles District