FDA WARNING_LETTER - Supreme Foods Incorporated - January 16, 2008

An FDA inspection of Supreme Foods Incorporated's seafood processing facility in Suffolk, Virginia, conducted on January 9-11 and 16, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render the firm's canned pasteurized crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was prepared, packed, or held under insanitary conditions. Specifically, the firm failed to conduct a proper hazard analysis and include "storage" as a critical control point for pathogen growth in its HACCP plan for "Refrigerated Seafood Products: Pasteurized Crabmeat, Salt Herring," violating 21 CFR 123.6(a) and (c)(2). Additionally, the firm did not implement the monitoring procedures and frequencies listed in its HACCP plan, failing to take product temperatures at the "Receiving refrigerated products" critical control point, instead relying on employees feeling the product by hand, which violates 21 CFR 123.6(b) and (c)(4). Supreme Foods is required to respond in writing within fifteen working days, detailing specific corrective actions, including supporting documentation like HACCP and verification records. Failure to promptly correct these violations may result in further FDA action, including product seizure and injunctions against the firm's operations. The letter emphasizes the firm's responsibility for ensuring full compliance with all applicable regulations.