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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Culinary Innovations LLC 11-Jul-02

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


July 11, 2002

VIA FEDERAL EXPRESS

Norman Davis, President
Culinary Innovations LLC
1700 Enterprise Way
Suites 107 & 108
Marietta, GA 30067

Warning Letter
02-ATL-31

Dear Mr. Davis:

On June 12, 2002, an investigator from the Food and Drug Administration (FDA), Robert P. Neligan, conducted an inspection of your, plant located at Marietta, Georgia1. During that inspection our investigator documented deviations from the Seafood HACCP regulations (21 CFR Part 123). These deviations cause your frozen ready-to-eat seafood products to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.

The HACCP deviations of concern are as follows:

1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, in order to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for frozen ready-to-eat vacuum-packed shrimp creole to control the food safety hazards of undeclared sulfiting agents and pathogen survival through cooking.

You or your designee must also determine through a hazard analysis whether there are food safety hazards that are reasonably likely to occur for the other seafood products handled by your firm. If so, then a HACCP plan should be developed and implemented to control those hazards.

2. You must adequately monitor sanitation conditions and practices during processing, in order to comply with 21 CFR 123.11(b). However, your firm has failed to monitor the following five areas of sanitation safety of water used for processing, prevention of cross contamination, protection from adulterants, proper labeling, storage and use of toxic compounds and exclusion of pests.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to 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.

This letter may not list all the deviations at your facility. You arc 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.

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.

Sincerely,

/S/

Ballard H. Graham, Director
Atlanta District

_______________________________________

1Mr. Neligan was accompanied by Sidney Shepherd and John Edwards, seafood safety officers with the Georgia Department of Agriculture.