FDA WARNING_LETTER - Pescamarca - April 26, 2010

An FDA inspection conducted from April 22-26, 2010, at Kingmar Seafood Corporation, a U.S. importer, revealed that shrimp imported from Pescamarca, Venezuela, were associated with serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA collected and evaluated Pescamarca's HACCP plan for shrimp, finding it inadequate. Specifically, the plan failed to list appropriate critical limits at the "shrimp reception" critical control point to control aquaculture drugs, as required by 21 CFR 123.6(c)(3). The certificates used did not ensure that drugs unapproved for use in the United States were not utilized. Additionally, the HACCP plan's "Packing" critical control point, which addresses the allergenic hazard of sodium bisulfite, was deficient. The critical limit for this CCP should mandate that all packaging materials declare the presence of sulfite and that each lot of packaging labels be checked upon receipt for this declaration. Failure to implement a compliant HACCP plan renders the firm's fish or fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Pescamarca must respond in writing within fifteen working days, outlining specific corrections, providing revised HACCP plans, monitoring records, and verification records. Failure to adequately respond may result in refusal of admission for imported products, including detention without physical examination (DWPE) under Import Alert #16-120.