FDA WARNING_LETTER - Yeshua Bendito, C.A. - June 14, 2024

On November 1, 2024, the FDA issued a Warning Letter to Yeshua Bendito, C.A., following a Foreign Remote Regulatory Assessment (FRRA) conducted from June 10-14, 2024, at their facility in Venezuela. The assessment revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm had not responded to the initial FDA RRA Observations letter.

The FDA determined that the firm's cooked ready-to-eat (RTE) refrigerated and frozen crab meat in reduced oxygen packaging (ROP) products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations include: 1. Failure to conduct a complete hazard analysis for RTE ROP crab meat, specifically omitting natural toxins, environmental chemicals (e.g., lead), and *Clostridium botulinum* toxin formation. For *C. botulinum*, the firm's frozen ROP products lacked proper labeling instructions ("Important, keep frozen until used, thaw under refrigeration immediately before use") and were improperly distributed as refrigerated. 2. The HACCP plan for RTE ROP crab meat lacks critical limits for cooling cooked crabs. The plan fails to specify cumulative cooling times to reach below 21.1°C (70°F) within 1 hour and