Morales Fishco – FDA Warning Letter, Jun 10, 2015

On November 9, 2015, the FDA issued a Warning Letter to Morales Fishco following an inspection on June 9-10, 2015, which found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA acknowledged the firm's July 31, 2015, response, but deemed it inadequate.

The primary violations include: 1. Failure to have a HACCP plan for frozen vacuum-packed amberjack fillets, mahi-mahi fillets, and vacuum-packaged kingklip to control histamine and Clostridium botulinum toxin formation, violating 21 CFR 123.6(a) and (b). 2. The existing HACCP plan for "Frozen Fish Fillets Vacuum Packed" does not list ciguatoxin and Clostridium botulinum toxin formation as reasonably likely food safety hazards, violating 21 CFR 123.6(a) and (c)(1).

These deficiencies render the firm's frozen vacuum-packaged fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Morales Fishco must respond in writing within 15 working days, outlining specific corrective actions, including a revised HACCP plan and five consecutive days of completed monitoring records. Failure to comply may result in refusal of admission