FDA WARNING_LETTER - Gold Star Seafood, Inc. - September 10, 2009

The FDA inspected Gold Star Seafood, Inc.'s facility in Chicago on multiple dates in August and September 2009, finding 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 failures render their refrigerated pasteurized, ready-to-eat canned crab meat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Specifically, the firm's HACCP plan for pasteurized crab meat contained inadequate critical temperature limits at receiving and storage critical control points, failing to control pathogen growth as required by 21 CFR 123.6(c)(3). Additionally, the plan's monitoring procedures and frequencies for these critical control points were inadequate to prevent pathogen growth and toxin formation, including Clostridium botulinum, violating 21 CFR 123.6(c)(4). The receiving monitoring procedure was deficient as a one-time truck temperature check provided no information on transit temperatures. Similarly, the storage monitoring procedure, checking temperatures only (b)(4) times daily, was insufficient to ensure temperatures did not exceed limits for more than two hours. The FDA requires a written response within fifteen working days detailing specific corrective actions, supported by documentation like HACCP and verification records. Failure to promptly correct these violations may result in further action, including product seizure and/or injunction against the firm's operations. The company is responsible for ensuring full compliance with all applicable regulations to prevent future violations.