FDA WARNING_LETTER - Gamma-A Sia - May 15, 2015

The FDA inspected Gamma-A Sia's seafood processing facility in Riga, Latvia, on May 14-15, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and the firm's July 6, 2015, response did not address the HACCP observations, leading to continued concerns about their canned fish products, which are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for "Canned Smoked Fish in Oil, Canned Smoked Fish in Sauces" failed to list Staphylococcus aureus (S. aureus) growth and toxin formation, and allergens (finfish, wheat) as reasonably likely food safety hazards. Controls for S. aureus growth during processing (e.g., limiting exposure above 21°C to less than 3 hours) and allergen declaration (visual label examination) were missing. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The HACCP plan did not list critical control points for the storage