FDA WARNING_LETTER - San Simeon Incorporated - July 24, 2009

On July 23-24, 2009, the FDA inspected San Simeon Incorporated in Albuquerque, NM, and found serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations (21 CFR Part 123). These deviations render the firm's pasteurized cooked crabmeat and scombroid-producing finfish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include: 1. **Lack of HACCP Plan:** The firm does not have a HACCP plan for pasteurized cooked crabmeat to control pathogen growth and toxin formation, including *Clostridium botulinum*, violating 21 CFR 123.6(a) and (b). 2. **Inadequate Critical Limits:** The HACCP plan for "Raw finfish, histamine producing" (e.g., Amberjack, Tuna) has inadequate critical limits at the Storage critical control point to control histamine growth. The plan lists "Continual temp control or storage on ice" without a specific temperature parameter, and histamine-forming fish were not stored on ice. FDA recommends storage at or below 40°F with continuous temperature monitoring. This violates 21 CFR 123.6(c)(3). 3. **Inappropriate Corrective Actions:** Corrective action plans for raw histamine-producing finfish at receiving and