FDA WARNING_LETTER - Carioto Produce Inc - November 03, 2010

The FDA inspected Carioto Produce, Inc.'s seafood processing facility from November 1-3, 2010, and found 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). These violations render their refrigerated ready-to-eat (RTE) canned pasteurized crabmeat and refrigerated tuna loins adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. Failure to have and implement a written HACCP plan for RTE canned pasteurized crabmeat to control pathogen growth and toxin formation, including *Clostridium botulinum*, as required by 21 CFR 123.6(a) and (b). 2. The firm's HACCP plan for histamine-forming species does not list receiving and refrigerated storage as critical control points for controlling histamine formation, violating 21 CFR 123.6(a) and (c)(2).

The FDA warns that failure to promptly correct these violations may result in further action, such as product seizure and/or injunction against the firm's operation. Carioto Produce, Inc. must respond in writing within fifteen working days, outlining specific corrective actions, including