FDA WARNING_LETTER - Blue Caribbean Foods Inc. - November 14, 2023

On November 13-14, 2023, the FDA inspected Blue Caribbean Foods Inc. (Kingstown Fish Market), identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's fresh (iced) yellowtail and big eye tuna are deemed adulterated.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The "Fresh Tuna Processing, Second Edition July 8th, 2022" HACCP plan lacks critical control points for verifying transportation conditions (scombrotoxin prevention), cumulative time/temperature controls for scombrotoxin, and allergen labeling for fish. 2. **Failure to Implement Monitoring and Recordkeeping (21 CFR 123.6(b)):** The firm did not follow monitoring and recordkeeping procedures for the Landing CCP (scombrotoxin), failing to provide harvest vessel records or histamine testing results. Chilling CCP records lacked critical limit observations, and "Tuna Fish Processing Record" for ice adequacy was inconsistent or blank. 3. **Missing/Inadequate Critical Limits (21 CFR 123.6(c)(3)):** Landing CCP critical limits for internal temperature were inadequate, lacking information for employees. Storage CCP temperature critical limit of "(b)(