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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Supreme Foods Incorporated 01-Apr-08

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410)779-5454
FAX: (410) 779-5705


FEI 1117873

April 1, 2008

Certified Mail
Return Receipt Requested

WARNING LETTER
#5645

Mr. Michael W. Dilday, President
Supreme Foods Incorporated
1201 Progress Road.
Suffolk, Virginia 23434-2145

Dear Mr. Dilday:

We inspected your seafood processing facility, located at 1201 Progress Road, Suffolk, Virginia on January 9-11, and 16, 2008. 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, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your canned pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulations, 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 conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points; to comply with 21 CFR 123.6(a) and(c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and the food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "Refrigerated Seafood Products: Pasteurized Crabmeat, Salt Herring" does not list the critical control point of "storage" for controlling the food safety hazard of pathogen growth and toxin format on. Moreover FDA recommends the use of equipment that is capable of providing a hard copy record that reflects continuous monitoring of temperatures on a 24 hour a day/seven day a week basis, with a daily check of the temperatures and the equipment.

2. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures and frequencies of taking product temperatures at the "Receiving refrigerated products" critical control point to control pathogens as listed in your HACCP plan for "Refrigerated Seafood Products: Pasteurized Crabmeat, Salt Herring". In practice, your firm was observed having employees use their hands to feel the product to assess the temperature.

Please be advised that taking product temperatures at receipt is only recommended for products that have not been in transit for extended time periods prior to receipt at your facility. For products that have been in transit for long periods of time, the Fish and Fisheries Products Hazards and Controls Guidance recommends that you obtain a monitoring record that provides a continuous read-out of temperatures (either product or ambient) that covers the entire transit time for the products. In addition, your firm's practice of having employees use their hands to feel the product to assess the temperature is never a recommended monitoring strategy for controlling the food safety hazard of pathogen growth and toxin formation.

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, or 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 the Food and Drug Administration, Attention: Jose R. Hernandez, Compliance Officer, USFDA, 2810 North Parham Road, Suite 160, Richmond, Virginia 23294. If you have questions regarding any issues in this letter, please contact Mr. Hernandez at (804)747-0124, extension 103.

Sincerely,

/S/

Evelyn Bonnin, Director
Baltimore District