|Issuer:||Atlanta District Office|
|Issued:||June 28, 2005||Closed:||
Department of Health and Human Services
Public Health Service
Atlanta District Office
June 28, 2005
VIA FEDERAL EXPRESS
Will Rece, President
5423 North Lake Drive
Lake City, GA 30260
Dear Mr. Rece:
On May 31- June 2, 2005, the United States Food and Drug Administration ("FDA") conducted an inspection of your seafood processing facility located at 5423 North Lake Drive, Lake City, Georgia. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Point (HACC'P) regulations, Title 21, Code of Federal Regulations . Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or to otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 442(a)(4) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 U.S.C. 342(a)(4). Accordingly, your seafood products containing shrimp and/or tuna (a scombroid fish), such as frozen coconut breaded shrimp and frozen tuna tataki, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.
At the conclusion of our inspection, the FDA investigator issued Form FDA 483, Inspectional Observations (copy enclosed), to William J. Rosenhoover, Plant Manager. The FDA 483 presents our investigator's evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations of concern are as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there an food safety hazards that are reasonably likely to occur for each kind of fish or fishery product that you process, to comply with 21 CFR 123.6(a). You also must have and implement a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, you firm's HACCP plan for raw seafood does not list the food safety hazards of undeclared sulfiting agents in shrimp products, and histamine formation in tuna (scombroid fish) products.
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 CFR 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 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 records, 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 Carlos A. Bonnin, 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 Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director