FDA WARNING_LETTER - Bakkavor Foods USA Inc - February 23, 2022

The FDA inspected a facility manufacturing ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée-style meals, and seafood products from February 7-23, 2022. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes) in 14 of 110 environmental swabs, including food-contact surfaces, indicating a resident strain. This led to the determination that RTE products were adulterated under 21 U.S.C. § 342(a)(4).

Violations of 21 CFR Part 117 (CGMP & PC rule) and 21 CFR Part 123 (Seafood HACCP) were cited. The facility failed to conduct a proper hazard analysis for environmental pathogens like *L. monocytogenes* and *Salmonella* for RTE foods, incorrectly deeming them "not reasonably likely to occur." Sanitation controls were not identified as preventive controls.

CGMP violations included inadequate cleaning and sanitizing of equipment (e.g., hose nozzles on floor, rusted cheese grinder, damaged tumbler seals, unclean conveyor belts), condensation dripping onto food and food-contact surfaces, and pooled water splashing onto in-process RTE food.

Seafood HACCP violations included a failure to list critical control points (CCPs) for finished product storage to control pathogen growth (including *Clostridium botulinum*) and