FDA WARNING_LETTER - Acme Smoked Fish Corp. - February 10, 2021

The FDA inspected a ready-to-eat (RTE) hot and cold smoked seafood processing facility in Brooklyn, NY, from January to February 2021. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) & Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Finished product samples of RTE cold smoked tuna tested positive for Salmonella. Environmental swabs revealed the presence of Listeria monocytogenes (L. monocytogenes). Whole Genome Sequencing (WGS) linked one Salmonella strain to an imported raw tuna sample from a foreign supplier and two clinical isolates, confirming its capability to cause human illness. WGS also linked an L. monocytogenes strain from the facility to four clinical isolates.

Key violations include inadequate corrective actions for Salmonella findings, failure to address the raw material source of contamination, and insufficient investigation into L. monocytogenes contamination. The facility's HACCP plan for cold smoked RTE non-scombroid cured fin fish lacked a critical control point for thawing to control pathogen growth and toxin formation, a repeat violation. Additionally, the facility failed to monitor conditions and practices with sufficient frequency to prevent cross-contamination, evidenced by raw and RTE product processing in the same uncleaned area and a drain hole allowing debris into a cooler storing RTE products. The plant was not maintained