FDA WARNING_LETTER - Discover Fresh Foods, LLC - January 22, 2024
Discuss this record with AI
The FDA inspected a refrigerated ready-to-eat (RTE) dips and spreads manufacturing facility at 211 Pine Road, Easley, SC, from December 11, 2023, to January 22, 2024. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).
Environmental samples collected by the FDA tested positive for *Listeria monocytogenes* (L. mono), a human pathogen, in three non-food-contact surfaces. Whole Genome Sequencing (WGS) analysis indicated the presence of a single, persistent strain of L. mono in the facility since at least November 2017, confirmed by multiple FDA, USDA FSIS, and Florida Department of Agriculture and Consumer Services (FDACS) samples over several years. This includes detections in finished products and environmental swabs.
The facility's RTE dips and spreads are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. The firm failed to implement adequate sanitation controls to prevent environmental pathogen recontamination, as required by 21 CFR 117.135(a)(1) and (c)(3). Specific observations included an employee splashing drain water onto food-contact surfaces during cleaning.
Despite the firm's corrective
ID · 604967d6-3821-4ca4-8f28-6b4cf124780a
Full citation text and observation details available on the Dashboard.