FDA WARNING_LETTER - ocean group inc. ( - December 21, 2023

The FDA inspected a seafood processing facility in Los Angeles, CA, from December 11-21, 2023, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in 34 of 100 swabs. Whole genome sequencing identified three strains of *L. monocytogenes*, with one strain matching four clinical isolates (2017, 2018, 2019, 2023).

The presence of *L. monocytogenes* and non-pathogenic *Listeria* species indicates inadequate sanitation and control measures, leading to adulterated ready-to-eat (RTE) salmon and tuna under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The facility failed to monitor sanitation conditions and practices, specifically regarding personnel hygiene and prevention of cross-contamination, as required by 21 CFR § 123.11(b) and 21 CFR § 117.10(b)(9).

The firm's responses, including a voluntary recall, cessation of RTE seafood processing, cleaning, and updated procedures, were deemed insufficient due to a lack of supporting documentation like environmental swab results