FDA WARNING_LETTER - Banner Smoked Fish Inc. - June 21, 2021

The FDA inspected a ready-to-eat (RTE) cold- and hot-smoked seafood facility in Brooklyn, NY, from May to June 2021. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in the facility, including on food-contact surfaces. Seven out of 101 environmental swabs were positive for L. monocytogenes, with two from food-contact surfaces. Whole genome sequencing linked one strain to a clinical isolate from an ill person. This was not the first instance, as two swabs were positive in December 2019.

The FDA also found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering RTE seafood products adulterated. Violations included inadequate monitoring of cleaning and sanitizing (e.g., cleaning racks outdoors in rain, dirty brushes, contaminated knife), insufficient protection against cross-contamination (exposed RTE salmon contacting soiled doors, backed-up floor drain), poor facility maintenance (cracked floors, damaged walls with mold, condensate dripping onto food), and improper storage of cleaning compounds.

The firm's responses, including a voluntary recall, cessation of manufacturing, and corrective actions like deep cleaning, facility repairs, and updated procedures, were reviewed. However, the revised "Listeria Sampling Program" lacked clarity on analysis methods, and sanitation monitoring forms were inadequate in frequency