FDA WARNING_LETTER - Judge Farms Inc - October 23, 2018

On October 15-23, 2018, the FDA inspected Judge Farms, Inc., a shell egg farm in Ansonia, Ohio, and found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR 118). These violations render their shell eggs adulterated under the FD&C Act and in violation of the PHS Act.

Key violations include: 1. **Inadequate SE Prevention Plan (21 CFR 118.4(a)):** The written plan failed to state that chicks would be procured from SE-monitored breeder flocks or detail corrective actions for positive pullet environmental testing. While a December 12, 2018 response addressed these, implementation will be verified. 2. **Improper Biosecurity Implementation (21 CFR 118.4(b)):** The footbath, intended for SE prevention, was not properly maintained. Employees/visitors did not allow sufficient contact time, and the solution was visibly dirty, contrary to instructions. A corrective action log was provided, but a long-term cleaning plan and documentation of following new solution instructions are lacking. 3. **Unsatisfactory Rodent Control (21 CFR 118.4(c)(1)):** The farm failed to take appropriate corrective actions when rodent activity exceeded their established threshold. Records