FDA WARNING_LETTER - Crimasa Criaderos De Mariscos S. A. - June 06, 2014

The FDA inspected Crimasa Criaderos De Mariscos S.A. in Duran, Ecuador, on June 5-6, 2014, identifying serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's subsequent response to the FDA-483 was deemed inadequate, specifically lacking a revised HACCP plan. Consequently, the firm's raw aquacultured shrimp products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include the HACCP plan's failure to list aquaculture drugs as a reasonably likely food safety hazard for received shrimp, violating 21 CFR 123.6(a) and (c)(1). Additionally, the monitoring frequency for undeclared sulfiting agents at the "Packing" critical control point was inadequate, contrary to 21 CFR 123.6(c)(4). The corrective action plan for sulfiting agents was also found insufficient, as it did not address the root cause of critical limit deviations, violating 21 CFR 123.7(b).

The FDA requires a written response within fifteen working days, detailing specific corrections, including revised HACCP plans and five consecutive days of monitoring records. Failure to comply may result in refusal of admission for imported products, including detention without physical examination (DWPE), and the assessment of re-inspection fees. The firm remains responsible for ensuring full compliance with all applicable regulations.