FDA WARNING_LETTER - Vincent Piazza, Jr. & Sons Seafood, Inc. - March 01, 2012

On February 27-March 1, 2012, FDA inspected Vincent Piazza, Jr. & Sons Seafood, Inc., finding serious violations of seafood HACCP (21 CFR 123) and CGMP (21 CFR 110) regulations, rendering products adulterated under 21 USC 342(a)(4).

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plan for aquacultured salmon, bass, and redfish to control aquaculture drugs, or for vacuum-packaged tuna steaks to control *Clostridium botulinum* toxin formation. The letter suggests specific oxygen transmission rates, immediate freezing with proper labeling, or Time/Temperature Integrators (TTIs) as controls for *C. botulinum*. 2. **Inadequate HACCP Plan CCPs:** The HACCP plan for scombrotoxin-forming fish (tuna, escolar, mahi-mahi, snapper) lacks a Critical Control Point (CCP) for processing to control toxin formation. 3. **Failure to Implement Monitoring:** The firm did not follow its HACCP plan's monitoring procedure for ice presence at the "Raw material storage" CCP for histamine control in escolar, tuna, mahi-mahi, and snapper. 4. **Inadequate Monitoring Procedures:** The HACCP plan's monitoring procedure for ice presence at the "Raw material storage" CCP is