FDA WARNING_LETTER - Martin Preferred Foods, L.P. - October 15, 2012

On November 15, 2012, the FDA issued a Warning Letter to Martin Preferred Foods, LP, following inspections of their San Antonio, Texas seafood processing facility from June 14-20, 2012, and October 11-15, 2012. The inspections revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fresh mahi-mahi, amberjack, and ready-to-eat crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan's receiving critical limit of "temperature ≤ 40°F" for incoming products was insufficient to control histamine formation in scombrotoxin species or pathogen growth in ready-to-eat seafood. The FDA guidance recommends specific transit temperature records or ice coverage. 2. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** The corrective actions for receiving and storage critical limit deviations were inadequate. For receiving, the plan stated "segregated and returned," but did not address correcting the cause of the deviation. For storage, the plan focused on getting the unit back to compliance without