Andrew Kauffman – FDA Warning Letter, Aug 8, 2017

On January 26, 2018, the FDA issued a Warning Letter to WR Yoder dba WRC Yoder Farm Organics following an August 8, 2017, inspection by the Iowa Department of Agriculture. The inspection revealed significant violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These violations render 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 violations include: 1. Failure to conduct environmental SE testing when laying hens were 40 to 45 weeks of age (21 CFR 118.5(a)). 2. Failure to properly implement the written SE prevention plan, specifically regarding the number of environmental samples taken for a poultry house over (b)(4) feet wide (21 CFR 118.4, 118.7(a)). 3. Failure to procure SE-monitored pullets or raise them under SE-monitored conditions, as the pullet environment was tested at 13 weeks instead of the required 14-16 weeks (21 CFR 118.4(a)). 4. Failure to conduct environmental SE testing 4