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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Greenville Loop Seafood, Inc. 11/8/11

  

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

Public Health Service
Food and Drug Administration
 

Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA  30309


November 8, 2011

VIA UPS

Jeffrey W. Scott, President/Owner
Greenville Loop Seafood, Inc.
5830 Greenville Loop Road
Wilmington, NC 28409-2319

WARNING LETTER
(12-ATL-01)

Dear Mr. Scott:

We inspected your seafood processing facility located at 5830 Greenville Loop Road in Wilmington, NC on August 22-23, 2011.  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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetics Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your Scombrotoxin species fish 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 regulations, and the Fish and Fishery Products Hazards and Controls Guidance through links in FDA’s internet home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and 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 (a) and (b). 

However, your firm does not have a HACCP plan for Scombrotoxin fish species to control the food safety hazard of Scombrotoxin (histamine) formation.  Your firm operates as both a primary and secondary processor of Scombrotoxin fish species and must have measures in place to control the hazard associated with receiving, storing, and distributing these products.  This is a repeat violation.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practice requirements in 21 CFR 110, to comply with 123.11(b).  However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces or is used in the manufacture of ice with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by your failure to document the safety of the private well water supply used at your facility. Review of your records reveal that the last documented private well water testing occurred on 10/15/2008.

We may take further regulatory action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 verifications 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 that exist at your facility. You are responsible for ensuring that your seafood processing plant is operating in compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the Current Good Manufacturing Practice regulation (21 CFR 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 U. S. Food and Drug Administration, Attention: Lakisha Morton, Compliance Officer, at 60 – 8th Street NE; Atlanta, GA 30309. If you have any questions regarding any issues in this letter, please contact Mrs. Morton at 404-253-1285.

Sincerely,

/s/

John R. Gridley
District Director
Atlanta District Office