FDA WARNING_LETTER - Comercial Comtesa S.A. - May 07, 2013

An FDA inspection of Comercial Comtesa S.A.'s seafood processing facility in Punta Arenas, Chile, on May 6-7, 2013, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Despite an FDA-483 and a promise to correct, no revised HACCP plan was submitted. The firm's frozen vacuum-packaged crabmeat products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to these conditions. Key deficiencies include the failure to identify Clostridium Botulinum as a food safety hazard (21 CFR 123.6(a) and (c)(1)), inadequate listing of critical control points for pathogenic bacteria growth during unrefrigerated processing and refrigerated storage (21 CFR 123.6(a) and (c)(2)), insufficient critical limits for cooking and cooling (21 CFR 123.6(c)(3)), inadequate monitoring procedures for critical control points (21 CFR 123.6(c)(4)), and inappropriate corrective action plans that do not address regaining control or preventing adulterated product from entering U.S. commerce (21 CFR 123.7(b)). The firm must respond within 15 working days with specific corrective steps, including a revised HACCP plan 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) under Import Alert #16-120, and assessment of re-inspection fees.