Inspections, Compliance, Enforcement, and Criminal Investigations
Cherry Point Seafood Company, Inc. 29-Sep-03
Department of Health and Human Services
Public Health Service
Atlanta District Office
September 29, 2003
VIA FEDERAL EXPRESS
Micah J. LaRoche, President
Cherry Point Seafood Company, Inc.
2789 Cherry Point Road
Wadmalaw Island, SC 29487
Dear Mr. LaRoche:
On July 22-24, 2003, FDA conducted an inspection of your seafood processing facility located at Wadmalaw Island, South Carolina. During that inspection, our investigators documented serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CRR 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, histamine-forming fish is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it 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 deviations were as follows:
You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures at the receiving critical control point listed in your HACCP plan to control the histamine formation hazard for scombrotoxin sensitive species. These procedures include collecting suppliers’ guarantees (harvest vessel records), and taking core temperatures for each lot of histamine-forming fish.
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 alI 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 tb 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.
Mary H. Woleske, Director