FDA WARNING_LETTER - F. Rozzo & Sons, Inc. - June 29, 2017

On August 21, 2017, the FDA issued a Warning Letter to F. Rozzo & Sons, Inc. following an inspection from June 20, 22, and 29, 2017. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The FDA determined that fresh yellowfin tuna loins, refrigerated ready-to-eat vacuum-packed cold smoked salmon, and refrigerated ready-to-eat pasteurized crabmeat were adulterated because they were prepared, packed, or held under conditions that could render them injurious to health.

Key violations included: 1. **Failure to implement HACCP monitoring procedures (21 CFR 123.6(b) and (c)(4)):** The firm did not follow monitoring, recordkeeping, and verification procedures for receiving and refrigerated storage of various products, leading to inadequate control of *Clostridium botulinum*, pathogen growth, toxin formation, and Scombrotoxin (Histamine) formation. This included lack of temperature monitoring during transit, continuous temperature monitoring in coolers, and ice checks. The firm's response regarding continuous monitoring coverage and verification was deemed inadequate. 2. **Inappropriate corrective actions in HACCP plans (21 CFR