Petaluma Farms dba Fallon Ranch – FDA Warning Letter, Apr 9, 2012

On September 5, 2012, the FDA issued a Warning Letter to Petaluma Farms following an inspection from March 27 to April 9, 2012, at their shell egg production facilities in Petaluma, California. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These violations render their 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. **Inadequate SE Prevention Plan:** The plan failed to include required measures for pullet environmental testing (14-16 weeks of age) and subsequent cleaning/disinfection for SE-positive results. Biosecurity measures lacked detail on cross-contamination prevention, exclusion of stray animals, and employee bird-keeping restrictions. Rodent and pest control sections lacked specific thresholds for unacceptable activity and detailed monitoring/control methods. Cleaning and disinfection procedures were incomplete, specifically omitting protocols for SE-positive egg tests. 2. **Failure to Procure SE-Monitored Pullets:** Pullets used in several laying houses were not subjected to SE environmental testing at the required 14-16 weeks of age, or not tested at all. 3. **Failure