FDA WARNING_LETTER - Pt. Bitung Mina Utama - June 04, 2011

On October 31, 2011, the FDA issued a Warning Letter to Pt. Bitung Mina Utama following an inspection of their seafood processing facility in Bitung, Indonesia, from June 2-4, 2011. The inspection revealed deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123), resulting in the issuance of an FDA-483. The firm's frozen vacuum-packaged raw tuna was 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 revised HACCP plan for tuna failed to identify pathogen growth and toxin formation (including *Clostridium botulinum* growth and toxin formation) and undeclared allergens associated with finfish species. Specifically, the CO treatment under reduced oxygen conditions introduces the *Clostridium botulinum* hazard, for which a critical limit of 3.3°C (38°F) or below is recommended. The continuous monitoring capability of the "Chilling Room" temperature recorder was unclear, and individual packages lacked instructions to "Keep Frozen, thaw under refrigeration immediately prior to use." 2. **Inadequate Critical Limits (21 CFR 123.6(