FDA WARNING_LETTER - Maine Harvest Seafood - July 10, 2009

On July 1, 8, and 10, 2009, the FDA inspected TMC Food, LLC. d.b.a. Maine-Harvest Seafood in Elmira, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render products like pasteurized canned crab meat, various shrimp, and several fish species adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant HACCP violations include the lack of a HACCP plan for wild and aquacultured shrimp to control sulfite additives, chemicals, and drugs. The firm failed to implement monitoring procedures for pasteurized canned crabmeat, specifically not checking for ice presence or recording cooler temperatures at receipt and storage critical control points to control *Clostridium botulinum* toxin formation. Record-keeping systems were inadequate, with missing cooler temperature and ice presence observations for multiple products. Additionally, monitoring frequencies for storage critical control points in HACCP plans for histamine, non-botulinum, and botulinum groups were insufficient, especially when the firm was not in operation.

Further violations of Current Good Manufacturing Practice included improper storage of equipment, failure to remove litter and waste attracting pests (e.g., animal feces, shellfish shells, overflowing dumpster), inadequate pest screening