FDA WARNING_LETTER - DELFINO BATTISTA SRL - February 25, 2019

The FDA issued a Warning Letter to Delfino Battista SRL following an inspection from February 22-25, 2019, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's anchovy products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plans:** The revised HACCP plans for "Anchovies in Oil Production," "Production Anchovies Salted From fresh product," and "Production Anchovies Salted From Semiprocessed" lack critical control points for in-process refrigerated storage to control pathogen growth and toxin formation, including *Clostridium botulinum* (C. botulinum), in uneviscerated fish. FDA recommends critical temperature limits below 38°F (3.3°C) for uneviscerated fish and below 40°F (4.4°C) for salted, eviscerated fish, with continuous temperature monitoring. Observations revealed refrigeration units storing raw fish above recommended temperatures, and records showed temperatures as high as (b)(4)°C ((b)(4)°F) in 2018. 2. **Inadequate Critical Limits:** * Receiving critical limits of "(b)(4