FDA WARNING_LETTER - Lanter Distributing - October 23, 2014

On October 21-23, 2014, the FDA inspected Lanter Distributing, LLC's seafood processing facility in Forest Park, GA, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's refrigerated, ready-to-eat seafood 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.

Key violations include: 1. Failure to conduct a hazard analysis for refrigerated, ready-to-eat seafood products (e.g., spreads and dips) to control the pathogen hazard, as required by 21 CFR 123.6(a) and (b). 2. Failure to adequately monitor sanitation conditions and practices, including protection of food/food contact surfaces, proper labeling/storage/use of toxic chemicals, and pest exclusion, as required by 21 CFR 123.11(b). 3. Lack of a HACCP-qualified individual to develop, reassess, and modify the HACCP plan and hazard analysis, and perform record reviews, as required by 21 CFR 123.10. The operations manager confirmed