The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) hot and cold smoked seafood processing facility located at 30 Gem Street, Brooklyn, NY 11222-2804, on January 6, 7, 11, 13, 19-21, 25, 26, 29 and February 10, 2021. During our inspection we collected finished product samples of several products and environmental samples (swabs) from various areas in your facility, including areas that are near food during processing operations and your food contact surfaces. FDA laboratory analyses of the finished product samples found the presence of Salmonella, a human pathogen, in your RTE cold smoked tuna product. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
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