FDA WARNING_LETTER - R&P; Seafood Corp. - April 14, 2010

On August 16, 2010, the FDA issued a Warning Letter to R&P Seafood Corp. following an inspection from April 9, 12, and 14, 2010. The inspection revealed 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).

The FDA found that the firm's histamine-forming species, including Tuna and Mahi-Mahi, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Failure to implement monitoring procedures:** The firm did not consistently cover tuna fillets with ice or record cooler temperatures as required by their HACCP plan for histamine formation control. 2. **Inadequate sanitation control records:** The firm failed to maintain comprehensive sanitation monitoring records for critical areas like water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, food protection, chemical control, employee health, and pest exclusion. The "Daily Sanitation Control Record" sheet also lacked a specific area for documenting corrections. 3. **Lack of HACCP plan verification:** The firm did not verify the calibration of process monitoring instruments, specifically thermometers used at the Storage critical