FDA WARNING_LETTER - Pranas S.A.

This Warning Letter, Reference No. # 394321, is a follow-up to a September 19, 2012, letter to Pranas S.A. regarding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for "Anchovies in Salt Brine." The FDA has not received a substantial response or documentation of corrections.

The firm's anchovies in salt brine products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under conditions that may render them injurious to health.

Key deviations that remain unaddressed include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan fails to identify food safety hazards of pathogen growth and toxin formation (specifically *Staphylococcus aureus*) and undeclared allergenic substances. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The HACCP plan lacks critical control points for *Clostridium botulinum* growth and toxin formation, and histamine formation, particularly at receipt of anchovies, during heading/gut