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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Big Island Seafood LLC 07-Apr-05

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

Public Health Service
Food and Drug Administration


Atlanta District Office
60 8th Sheet, N.E.
Atlanta, Georgla 30309


April 7, 2005


Francis Major, Owner
Big Island Seafood LLC
146 Forest Parkway
Forest Park, GA 30297-2020

Warning Letter

Dear Ms. Major:

On March 7-11, 2005, FDA conducted an inspection of your seafood processing facility located at 146 Forest Parkway, Forest Park, Georgia. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis Critical Control Point (HACCP) regulations, contained in Title 21, Code of Federal Reoulations, Part 123 (21 C.F.R. Part 123). In accordance with 21 C.F.R. § 123.6(g), failure of a processor to have and Implement a HACCP plan that complies with this section, or otherwise operate In accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a}(4). Accordingly, your canned pasteurized crab meat and histamine prone fish are adulterated in that these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.

The deviations of concern are as follows:

1 . You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, as required by 21 C.F.R. § 123.0(b). Your firm does not have a HACCP plan for canned pasteurized crab meat to control the food safety hazards of pathogen growth and toxin formation, specifically Clostridium botulinum.

2. You must implement the record keeping system listed in your HACCP plan, as required by 21 C.F.R. § 123.6(c). Your firm did not record monitoring observations at the receiving critical control point (CCP) to control the histamine formation hazard listed in your HACCP plan for histamine prone fish received from another processor. Our investigator identified several shipments of histamine prone fish received by your firm since June 2004, for which there were no records of the internal temperature of the incoming fish.

This letter may not list all the deviations at your facility . You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

We may take further action, without additional notice, if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of HACCP plans, and HACCP monitoring reoords, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Please send your reply to Karen Y. Dodson, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mrs. Dodson at (404) 253-1299.


Mary H . Woleske, Director
Atlanta District