FDA WARNING_LETTER - HPC Foods, Ltd. - March 23, 2012

On March 19, 20, 21, and 23, 2012, the FDA inspected HPC Foods, Ltd.'s seafood processing facilities in Honolulu, Hawaii, and found 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 firm's refrigerated, ready-to-eat, raw Lomi salmon was deemed adulterated due to insanitary conditions.

Key violations include: 1. **HACCP Plan Deficiency (Allergens):** The HACCP plan for "Lomi Salmon" failed to list finfish as a food safety hazard (Allergens), as required by 21 CFR 123.6(a) and (c)(1). 2. **Missing Critical Control Point (Thawing):** The "Lomi Processing" HACCP plan did not include thawing as a critical control point to control pathogen growth, specifically *Clostridium botulinum*, during the thawing of vacuum-sealed salmon packages. The FDA observed thawing at temperatures conducive to toxin formation. 3. **Inadequate Critical Limits (Refrigerated Storage):** The HACCP plans for "Lomi (raw/finished)" and "Lomi Processing" listed inadequate critical limits for refrigerated storage, failing to control pathogen growth and toxin formation.