Acme Smoked Fish Corp.
Outcome
FDA issued a warning letter on July 12, 2021, after a January–February 2021 inspection of Acme Smoked Fish Corp.'s Brooklyn, New York ready-to-eat smoked seafood facility found Salmonella in finished cold-smoked tuna product and Listeria monocytogenes in multiple environmental swabs — violations of seafood HACCP regulations and CGMP requirements.
Details
Acme Smoked Fish Corp. — Salmonella in RTE Product / Listeria in Environment / FDA Warning Letter (2021)
Outcome: FDA issued a warning letter on July 12, 2021, after a multi-day inspection from January through February 2021 of Acme Smoked Fish Corp.'s Brooklyn, New York ready-to-eat hot and cold smoked seafood processing facility found Salmonella in finished cold-smoked tuna product and Listeria monocytogenes in multiple environmental swabs — serious violations of the seafood HACCP regulations (21 CFR Part 123) and CGMP requirements.
Acme Smoked Fish Corp. operates a large ready-to-eat smoked seafood processing facility in Brooklyn, New York, producing hot and cold smoked fish products including smoked salmon, smoked tuna, and other smoked seafood distributed to retail and food service customers. FDA conducted a comprehensive inspection spanning January 6, 7, 11, 13, 19–21, 25, 26, and 29, and February 10, 2021.
The inspection found two distinct pathogen contamination problems: (1) FDA laboratory analysis confirmed the presence of Salmonella in the firm's finished, ready-to-eat cold-smoked tuna product — meaning the product was adulterated under the FDCA and the facility's HACCP critical limits for the smoking process had either been set too low or were not being maintained; and (2) FDA environmental swab analysis identified Listeria monocytogenes in multiple locations within the facility, indicating the post-processing environment posed ongoing contamination risk to finished RTE products.
Acme Smoked Fish is one of the largest smoked fish processors in the United States, making this warning letter significant in terms of national RTE seafood supply chain exposure. The warning letter required a comprehensive written corrective action response within 15 working days.
Primary Source: FDA Warning Letters | FDA
How Crucible Prevents This
The simultaneous presence of Salmonella in a finished RTE product and Listeria monocytogenes in environmental swabs at the same smoked seafood facility indicates dual concurrent contamination failure — both in the finished product kill-step and in the post-processing environment. For a HACCP-regulated seafood facility, finding pathogen in finished product means the validated critical control point failed. Crucible's session-gate enforcement would require documented confirmation that the CCP monitoring log for the current production period showed no deviations before production proceeds — surfacing a CCP failure before product distribution rather than at the FDA inspection stage.
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