FDA WARNING_LETTER - Gravel Ridge Farms - September 25, 2018

The FDA issued a Warning Letter to Gravel Ridge Farms following an inspection from September 5-25, 2018, initiated due to a multi-state Salmonella Enteritidis (SE) outbreak. The outbreak infected 45 people in 12 states, with the same SE strain found in environmental swabs from the farm's egg laying houses No. 2 and No. 4, genetically identical to clinical isolates. FDA and CDC determined the farm's shell eggs were the likely source. The inspection revealed significant violations of FDA's egg safety rule, 21 CFR Part 118, rendering the shell eggs adulterated under Section 402(a)(4) of the FD&C Act and in violation of Section 361(a) of the PHS Act. Key deficiencies included the absence of a written SE prevention plan, as required by 21 CFR 118.4, and inadequate measures for pullet monitoring and record-keeping (21 CFR 118.4(a), 118.10(a)(2)). Biosecurity failures were noted, such as a lack of written procedures for limiting visitors, preventing cross-contamination by personnel and equipment, and controlling pests (21 CFR 118.4(b)). Specific observations included unmonitored visitors, unsanitized egg baskets, and employees moving between houses without changing protective gear. The firm also failed to monitor for rodents and flies, and did not eliminate pest harborages (21 CFR 118.4(c)). Furthermore, environmental SE testing was not conducted for each poultry house (21 CFR 118.7(a)) or for flocks at 40-45 weeks of age (21 CFR 118.5(a)). The firm voluntarily recalled eggs, depopulated flocks, and ceased production, stating they are unlikely to resume operations. FDA requires prompt corrective actions, documented within 15 working days, with verification during future inspections.