Unknown Company – FDA EIR, Nov 1, 2024

This FDA Summary Report details findings from an environmental sampling prioritization conducted as part of a FY21 HAFW5 Compliance Follow-up Inspection. While the specific company name is not identified, the inspection and sampling were initiated around April 15, 2021, with laboratory analysis concluding between April 28, 2021, and June 18, 2021. The primary issues identified were adverse microbiological findings. Environmental swabs (Sample Number 1134381) tested positive for Salmonella poly B, H antigen (+) in one sub-sample and Listeria innocua in multiple other sub-samples (11A, 12A, 19A, 21A, 28A, 32A, 38A), indicating the presence of these pathogens in the facility's environment. The inspection and sampling adhered to regulatory frameworks including DFPG 21-08, Field Alert #57, and Field Bulletin 30. Despite these adverse findings, the district's final disposition, authorized on June 18, 2021, stated "Regulatory Action Not Indicated," suggesting that, at the time of the report's conclusion, no formal enforcement action was deemed necessary for this specific sample incident.