FDA WARNING_LETTER - Ipswich Shellfish Co., Inc. - May 22, 2008

An FDA inspection of Ipswich Shellfish Co., Inc.'s seafood processing facility in Branford, Connecticut, conducted on May 19, 20, and 22, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). The primary violation identified was the firm's failure to implement the record-keeping system outlined in its HACCP plans, specifically not recording temperature monitoring observations at the receiving critical control point for histamine-producing seafood products and pasteurized crabmeat on multiple occasions, as required by 21 CFR 123.6(b) and (c)(7). This non-compliance renders the firm's mahi mahi, tuna, and pasteurized crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. The FDA requires a written response within fifteen working days detailing specific corrective actions, including supporting documentation like HACCP and verification records. Failure to promptly correct these violations may result in further regulatory action, such as product seizure or an injunction against the firm's operations.