FDA WARNING_LETTER - Maria's Fresh Seafood Market, L.L.C. - June 16, 2008

On June 16, 2008, the FDA inspected Maria's Fresh Seafood Market, L.L.C., finding serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110). Consequently, Fresh Cooked Crabmeat, Pasteurized Canned Crabmeat, and Fresh Whole Tuna were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct a hazard analysis and implement written HACCP plans for fresh, cooked crabmeat (pathogen growth) and canned, pasteurized crabmeat (pathogen growth and *Clostridium botulinum* toxin formation), violating 21 CFR 123.6(a) and (b). 2. Inadequate monitoring procedures in the "Tuna" HACCP plan at the "Receiving" critical control point for histamine formation, lacking sufficient detail on "What" will be monitored and appropriate methods for transit times over four hours, violating 21 CFR 123.6(c)(4). 3. Inadequate monitoring procedures in the "Tuna" HACCP plan at the "Storage" critical control point for histamine formation, with inappropriate monitoring methods and frequency, violating 21 CFR 123.