FDA WARNING_LETTER - Emerson Seafood, Inc. - April 04, 2008

On June 19, 2008, the FDA issued a Warning Letter to Emerson Seafood, Inc., following an inspection from March 31 to April 4, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

A significant violation identified was the firm's failure to have a HACCP plan for aqua cultured fish (Carp, Tilapia, Buffalo fish) to control food safety hazards such as chemical contaminants and drugs, as required by 21 CFR 123.6(a) and (b). This renders the firm's aqua cultured fish products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), meaning they were prepared, packed, or held under insanitary conditions.

Additionally, Emerson Seafood, Inc. was found to be in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H, for failing to register its facility with the FDA. Failure to register is a prohibited act under Section 301(dd) of the Act.

The FDA requires immediate registration of the facility and prompt correction of all violations