FDA WARNING_LETTER - Stuart’s Seafood Market, Ltd. - October 15, 2012

On October 10 and 15, 2012, the FDA inspected Stuart's Seafood Market, Ltd. in Amagansett, New York, 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 regulation (21 CFR Part 110). These violations render the firm's refrigerated ready-to-eat pasteurized canned crabmeat and raw tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. Failure to conduct a hazard analysis and implement a written HACCP plan for refrigerated ready-to-eat pasteurized canned crabmeat to control pathogen growth, including *Clostridium botulinum*, as required by 21 CFR 123.6(a) and (b). 2. Failure to implement the record-keeping system listed in the HACCP plan for raw tuna, specifically not recording monitoring observations at the receiving critical control point to control scombrotoxin (histamine) formation, as required by 21 CFR 123.6(b) and (c)(7). For example, monitoring records did not show appropriate recording of visual checks for ice or continuous temperature records during transport of