FDA WARNING_LETTER - Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) - April 08, 2011

On April 7-8, 2011, the FDA inspected Procesadora El Cangrejito Del Mar (PROCAMAR) in Venezuela, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and subsequent responses from PROCAMAR were deemed inadequate.

The FDA found PROCAMAR's crabmeat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Specific deficiencies in their HACCP plan for "Pre Cooked Crab Meat" include:

1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(2)):** The HACCP plan failed to list critical control points for in-process refrigerated storage and cooling of cooked crabs to control bacterial pathogen growth. FDA recommends continuous temperature recording for coolers (40°F or below) and specific cooling parameters (140°F to 70°F within 2 hours, then to 40°F within an additional 4 hours). 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** Monitoring procedures at the Cooking critical control point were inadequate, with FDA recommending continuous monitoring of temperature and pressure. Monitoring for Refrigerated Storage was also insufficient, with