FDA WARNING_LETTER - Peslasa S.A. - May 14, 2010

On August 19, 2010, the FDA issued a Warning Letter to Peslasa S.A. following an inspection of their seafood processing facility in Guyaquil, Ecuador, from May 13-14, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The FDA determined that Peslasa S.A.'s moonfish and other scombrotoxin (histamine) forming fish were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Failure to implement monitoring procedures:** The firm did not follow its HACCP plan's monitoring procedures and frequencies for histamine formation at the Reception Fresh Fish critical control point. This included not conducting histamine testing on scombrotoxin-forming fish lots exported to the USA, conducting sensory exams on fewer fish than specified, and monitoring ice/water temperatures instead of internal fish temperatures. 2. **Inadequate Hazard Analysis and HACCP Plan:** The HACCP plan for frozen headed and gutted scombrotoxin-forming fish failed to list "transit (receiving truck)" as a critical control point for histamine formation,