Inspections, Compliance, Enforcement, and Criminal Investigations
Seafood Express, Inc. 14-Sep-05
Department of Health and Human Services
Public Health Service
Atlanta Dristrlct Office
September 14, 2005
VIA FEDERAL EXPRESS
William S. Benfield, President
Seafood Express, Inc.
1122 Sea Mountain Highway
North Myrtle Beach, SC 29582-2213
Dear Mr. Benfield:
We inspected your seafood processing facility, located at 1122 Sea Mountain Highway, North Myrtle Beach, SC on August 23-24, 2005. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drag, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly, your products (pasteurized & fresh Crabmeat, Tuna and Mahi Mahi) are adulterated, in that they have been prepared, packed; or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). Your firm does not have a HACCP plan for fresh & pasteurized Crabmeat to control the food safety hazard of pathogens.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan for scombroid toxin-forming species, such as Tuna and Mahi Mahi, to comply with 21 CFR 123.6(b) and (c)(4). For over five months your firm did not follow the monitoring procedures and frequency of monitoring for the presence of ice and core temperature of Tuna and Mahi Mahi at the "Receiving" critical control point, that is necessary to control the formation of histamine toxin, as listed in your HACCP plan.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). For over five months your firm did not document any monitoring for the presence of ice and core temperature of your Tuna and Mahi Mahi at the "Receiving" critical control point.
4. Your HACCP plan must list the critical control points for each identified food safety hazard specified in 21 CFR 123.6(c)(2). Your HACCP plan for Tuna and Mahi Mahi does not list the critical control point at "Storage" that is necessary to control the formation of histamine toxin.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11( c). For over five months your firm has not monitored and maintained sanitation control records for various conditions and practices during the processing of crabmeat and fish products, such as, water that comes into contact with food and food contact surfaces, condition and cleanliness of food contact substances, and prevention of cross-contamination from insanitary objects.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (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 James MacLaughlin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issues in this letter, please contact Mr. MacLaughlin at (404)253-1220.
Mary H. Woleske, Director