FDA WARNING_LETTER - Marine Foods Express, Ltd - August 16, 2012

On August 14-16, 2012, the FDA inspected Marine Foods Express, LTD, a seafood processor and importer, identifying serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. Consequently, their refrigerated pasteurized crabmeat, imported frozen tilapia, and imported frozen cooked whole crawfish are deemed adulterated.

Key violations include: 1. **HACCP Plan Deficiencies:** The HACCP plan for refrigerated pasteurized crabmeat failed to list *Clostridium botulinum* as a reasonably likely food safety hazard. 2. **Inadequate Critical Limits:** The critical limit for receiving refrigerated pasteurized crabmeat ("product must not be above (b)(4) deg upon receipt") was insufficient to control pathogen growth, including *C. botulinum*, as it didn't ensure temperatures at or below 40°F throughout transit. 3. **Insufficient Monitoring Procedures:** The monitoring procedure for refrigerated pasteurized crabmeat storage (manual temperature checks) was inadequate; continuous temperature recording is recommended. 4. **Inappropriate Corrective Actions:** Corrective actions for receiving ("refuse product") and storage ("destroy product" if over (b)(4) deg) of refrigerated pasteurized crabmeat were deemed insufficient to address the root cause or prevent recurrence. 5. **Lack of Importer Verification Procedures