FDA WARNING_LETTER - Willharvdoit Corporation - June 10, 2011

On May 10 to June 10, 2011, the FDA inspected Willharvdoit Corporation's seafood processing facility, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR 110). The inspection found Tuna Salad and fish patty sandwiches to be adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** No HACCP plan for frozen ready-to-eat fish patty sandwiches to control pathogen growth and undeclared allergens (21 CFR 123.6(a) and (b)). 2. **Inadequate Hazard Analysis:** The revised HACCP plan for tuna salad sandwiches failed to list *Clostridium botulinum* growth and toxin formation, and histamine as reasonably likely food safety hazards (21 CFR 123.6(a) and (c)(1)). The pH of raw material tuna and finished sandwiches (5.2-5.88) was not low enough to inhibit *C. botulinum* in oxygen-impermeable packaging, requiring a secondary barrier like pH control to 5.0 or below, or temperature critical limits of 38°F with time and temperature integr