Pesnusan Cia Ltda – FDA Warning Letter, May 11, 2020

On October 22, 2010, the FDA issued a Warning Letter to Pesnusan Cia Ltda. following an inspection of their seafood processing facility in Manta, Ecuador, on May 10-11, 2010, and a review of their HACCP plan and supporting documents submitted on May 20, 2010. The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their scombrotoxin-forming fish products, including Fresh Fish HG, Fresh Cuts, and Frozen Cuts, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and CCPs (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for Fresh Fish HG failed to list "Storage Before Loading on Trucks" and "Transportation By Truck" as critical control points for pathogen growth, toxin formation, and scombrotoxin formation, despite significant uncontrolled exposure times. The Fresh Cuts HACCP plan also omitted "TTI Application" as a CCP for *Clostridium botulinum* growth and toxin formation in vacuum-packaged products. 2. **Inadequate Monitoring Procedures and Frequency (21 CFR 123.6(c)(