FDA WARNING_LETTER - Gold Star Smoked Fish Corp. - May 12, 2017

On December 15, 2017, the FDA issued a Warning Letter to Gold Star Smoked Fish Corp. following an inspection from April 26 to May 12, 2017. The inspection revealed that the facility was processing ready-to-eat (RTE) cold and hot smoked seafood products under insanitary conditions, causing them to be adulterated under 21 U.S.C. § 342(a)(4).

FDA laboratory analyses of environmental samples identified the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen. Specifically, 15 out of 110 environmental swabs were positive for L. monocytogenes, with 11 positives from stainless steel cart wheels used for thawing, brining, and transporting seafood. Whole Genome Sequencing (WGS) analysis confirmed two strains of L. monocytogenes present in the facility, with isolates from both the 2016 and 2017 inspections, indicating a persistent resident strain or niche harborage site.

This recurring presence demonstrates inadequate sanitation procedures to control or eliminate the pathogen. While the firm responded on June 5, 2017, outlining corrective actions like cleaning, sanitizing, and intensified environmental sampling, the FDA cannot verify the adequacy of these measures without further inspection. The letter advises the firm to review FDA's draft guidance on *Listeria monocytogenes*