FDA WARNING_LETTER - S.A.R.L. PACIFIC TUNA - September 21, 2015

The FDA issued a Warning Letter to S.A.R.L. Pacific Tuna on September 10, 2015, following a review of their HACCP plans ("Whole Fresh Fish Export" and "Export of Fresh Vacuum Packed Loins") and associated monitoring records. The FDA found serious deviations from seafood HACCP regulations (21 CFR Part 123), rendering the firm's fish products, including Tuna, Mahi-Mahi, and Marlin, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** HACCP plans failed to list pathogen growth as a reasonably likely food safety hazard, particularly for fish intended for raw consumption, relying insufficiently on sanitation procedures. (21 CFR 123.6(a) and (c)(1)) 2. **Missing Critical Control Points (CCPs):** The "Export of Fresh Vacuum Packed Loins" HACCP plan lacked CCPs for the use of Time-Temperature Indicators (TTIs) or oxygen-permeable packaging to control *Clostridium botulinum* growth and toxin formation in reduced oxygen packaged seafood. (21 CFR 123.6(a) and (c)(2)) 3. **Inadequate Critical Limits:** * Critical limits for scombrotoxin formation at the receiving CCP were insufficient.