FDA WARNING_LETTER - Grupo VPAS C.A. - January 26, 2024

On January 22-26, 2024, the FDA conducted a Foreign Remote Regulatory Assessment (FRRA) of Grupo VPAS C.A.'s seafood processing facility in Caracas, Venezuela, revealing serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's fresh-frozen, IQF Medregal fillet with skin and without skin HACCP plan was deemed adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis and Critical Control Points:** The HACCP plan failed to list critical control points for vessel offloading (monitoring internal temperatures) and transportation conditions (preventing scombrotoxin/histamine formation) from the offloading site to the facility. 2. **Inadequate Critical Limits:** Critical limits for histamine control at the (b)(4) step PCC1 and (b)(4) step PCC2 were insufficient. Specifically, the critical limit of "(b)(4)" for decomposition was inadequate, lacking a threshold of less than 2.5% for persistent odors. The monitoring procedure for the number of fish tested was also inadequate. The critical limit of "(b)(4)" for storage was insufficient, as it only monitored internal fish temperature, not overall holding conditions like ice or cooler temperatures. 3. **Failure to