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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pride of the South Catfish, Inc. 16-Nov-06

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

Public Health Service
Food and Drug Administration

 

New Orleans District
404 BNA Drive
Building 200 - Suite 600
Nashville, TN 37217
Telephone: (815) 386-7801
FAX. (695) 368-7802


 

November 16, 2006

WARNING LETTER NO. 2007-NOL- 05

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Walter D. Norris, President
Pride of the South Catfish, Inc.
1075 Highway 388
Brooksville, Mississippi 39739

Dear Mr. Norris:

On July 25 and 28, 2006, an investigator with the U.S. Food and Drug Administration (FDA) inspected your seafood importer establishment, located at Highway 388, Brooksville, Mississippi. He found 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 123). You may find specific requirements for imported fish and fishery products in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123. In accordance with 21 CFR 123.12(d), there must be evidence all fish and fishery products offered for entry into the United States have been processed under conditions which comply with 21 CFR 123. If assurances do not exist the imported fish or fishery product has been processed under conditions which are equivalent to those required of domestic processors under 21 CFR 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 USC 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR 123, your aquaculture raised catfish are adulterated under Section 402(a)(4) of the Act [21 USC 342(a)(4)], in which 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 Internet home page at www.fda.gov.

Your significant violation was as follows:

1. You must implement an affirmative step which ensures 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)(ii). However, your firm did not perform an affirmative step for frozen aquaculture raised/farmed channel catfish manufactured [redacted] by located in China.

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 USC 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 HA.CCP and importer verification records, and records which document the performance and results of your firm's affirmative steps, or other useful information which 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 your establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR 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 you import into the United States.

Please send your reply to the Food and Drug Administration, Attention: Mark Rivero, Compliance Officer, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (5f14) 219-
8818, extension 103.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District