Inspections, Compliance, Enforcement, and Criminal Investigations
Norman Seafood Inc 13-Aug-02
Department of Health and Human Services
Public Health Service
Atlanta District Office
August 13, 2002
RETURN RECEIPT REOUESTED
Brantley P. Norman, Sr., President
Norman Seafood, Inc.
P.O. Box 37
Oriental, NC 28571
Dear Mr. Norman:
On June 25, 26, & July 10, 2002, an investigator from the Food and Drug Administration (FDA), conducted an inspection of your seafood repacking facility located at Oriental, North Carolina. During that inspection, our investigator documented deviations from the Seafood HACCP regulations (21 CFR Part 123). These deviations cause your fresh, ready-to-eat crabmeat to be inviolation 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, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for fresh crabmeat to control the food safety hazard of "pathogen growth and toxin formation as a result of time/temperature abuse."
2. You must have sanitation control records that document monitoring and corrections, in order to comply with 21 CFR 123.11(b). However, there were no such records available when our investigator requested to see them. We acknowledge that approximately two weeks later, during the close-out meeting with the FDA investigator, you provided her with sanitation records. In the future, please ensure that these records are maintained at the plant, or are otherwise readily available for official review and copying in accordance with 21 CFR 123.9(c).
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 finn 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 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.
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.
Barbara A. Wood, Acting Director