FDA WARNING_LETTER - Procesadora Vikingo C.A. - September 15, 2023

The FDA conducted a Remote Regulatory Assessment of Procesadora Vikingo C.A. from September 11-15, 2023, evaluating their HACCP program for refrigerated cooked, ready-to-eat (RTE) crabmeat. The assessment found the seafood products adulterated under 21 CFR 402(a)(4) due to insanitary conditions.

Violations include: 1. Failure to take corrective action when cooked crabmeat deviated from the critical limit for cooking time (e.g., batches cooked at (b)(4) minutes instead of (b)(4) minutes), with affected product distributed to the U.S. (21 CFR 123.7(a)). 2. HACCP plan for RTE crabmeat does not list undeclared allergens (blue crabs) as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 3. HACCP plan lacks a critical control point for ambient cooling to control pathogen growth, despite crabs being cooled at ambient temperature for approximately (b)(4) minutes post-cooking (21 CFR 123.6(a) and (c)(2)). 4. HACCP plan's critical limits for "Cooked Crab Refrigeration" are inadequate to control pathogen growth (21 CFR 123.6(c)(3)).