FDA WARNING_LETTER - Rose Acre Farms, Inc. White County Egg Farm - April 28, 2011

The FDA issued a Warning Letter to Rose Acre Farms, Inc. following an inspection of its White County Egg Farm from April 19-28, 2011. Environmental samples collected during the inspection tested positive for Salmonella enteritidis (SE) in egg laying houses. The inspection revealed significant violations of the Prevention of Salmonella enteritidis in Shell Eggs regulation (21 CFR Part 118), rendering the firm's shell eggs adulterated under the FFD&C Act Section 402(a)(4) and in violation of the PHS Act Sections 361(a) and 368(a) due to insanitary conditions. Key violations included the failure to implement adequate rodent control measures, despite the firm's own monitoring indicating unacceptable rodent activity, with over 21,000 rodents trapped and numerous live rodents observed (21 CFR 118.4(c)(1)). Additionally, the firm failed to fully implement and follow its written SE prevention plan (21 CFR 118.4), as evidenced by ineffective corrective actions for rodent populations and observed structural deficiencies like holes in housing that allowed pest ingress. The FDA deemed the firm's response to the FDA 483 inadequate, lacking root cause identification and timelines. The FDA requested a meeting to discuss comprehensive, whole-farm corrective actions, including egg diversion, improved rodent control, and structural repairs, to achieve compliance and prevent recurrence. Failure to correct violations may result in legal action.