FDA WARNING_LETTER - PESCAMOZ LDA - June 23, 2023

The FDA issued a Warning Letter to PESCAMOZ LDA, a seafood processing facility in Beira, Sofala, Mozambique, following an inspection conducted on June 22-23, 2023. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, as outlined in Title 21, Code of Federal Regulations (21 CFR Part 123). The FDA identified that PESCAMOZ LDA lacks a HACCP plan for its tuna and swordfish products, which is necessary to control food safety hazards such as scombrotoxin formation and pathogenic bacterial growth due to time and temperature abuse. Additionally, the firm does not have a plan for individually frozen, vacuum-packaged fish to prevent Clostridium botulinum growth and toxin formation.

The FDA has deemed the company's tuna and swordfish products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they may have been prepared under conditions that could render them injurious to health. Despite receiving corrective action reports from PESCAMOZ LDA, the FDA found the responses inadequate in addressing the HACCP program concerns.

The company is required to conduct a hazard analysis and implement a written HACCP plan for each fish and fishery product. PESCAMOZ LDA must submit a detailed response within 15 working days, outlining corrective actions and providing documentation of compliance. Failure to address these issues may result in further regulatory actions, including the detention of imported products without physical examination. The FDA has advised PESCAMOZ LDA to ensure compliance with all applicable regulations and to prevent future violations.