Inspections, Compliance, Enforcement, and Criminal Investigations
Clark's Marina & Seafood 16-Sep-04
Department of Health and Human Services
Public Health Service
60 8th Street, N.E.
September 16, 2004
RETURN RECEIPT REQUESTED
Mitchell P. Newman, Owner
Clark’s Marina & Seafood
P.O. Box 13
Swan Quarter, NC 27885-0013
Dear Mr. Newman:
On June 7 - 8, 2004, FDA conducted an inspection of your seafood processing facility located at 275 Landing Road, Swan Quarter, North Carolina. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) 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 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 fresh, shrimp are adulteratad, 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.
The deviation of concern is as follows:
You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the “Receiving“ critical control point to control the hazard of undeclared sulfites listed in your HACCP plan for fresh, headed shrimp.
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 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 tist 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, NE, 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