FDA WARNING_LETTER - Greenville Loop Seafood, Inc. - August 23, 2011

On August 22-23, 2011, the FDA inspected a seafood processing facility at 5830 Greenville Loop Road in Wilmington, NC, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110).

The facility's Scombrotoxin species fish were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. § 342(a)(4)) due to insanitary preparation, packing, or holding conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for Scombrotoxin fish species to control Scombrotoxin (histamine) formation, a repeat violation of 21 CFR 123.6(a) and (b). As both a primary and secondary processor, the firm must control hazards during receiving, storing, and distributing these products. 2. **Insufficient Sanitation Monitoring:** The firm did not sufficiently monitor the safety of its private well water supply, which contacts food or food contact surfaces and is used for ice manufacturing, violating 21 CFR 123.