PESCAMOZ LDA Warning Letter Details

Summary

PESCAMOZ LDA, a Mozambique-based seafood processor, violated FDA's Hazard Analysis and Critical Control Point (HACCP) regulations for seafood processing, rendering their tuna and swordfish products adulterated and potentially injurious to health. During a June 2023 inspection, FDA identified serious deficiencies in the company's HACCP program implementation under 21 CFR Part 123, and found that the firm's submitted corrective action responses did not adequately address the documented violations. The violations were particularly concerning given a prior consumer complaint from July 2021 involving scombrotoxin poisoning from the company's yellowfin tuna loins, indicating a pattern of safety control failures.