Iowa Egg Company Inc. – FDA Warning Letter, Jun 29, 2023

On December 15, 2023, the FDA issued a Warning Letter to Mr. Dang, owner of a shell egg farm and processing facility in Osage, IA, following an inspection on June 28-29, 2023, by the Iowa Department of Agriculture. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118), rendering the shell eggs adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate SE Prevention Plan:** The written plan lacked requirements for SE-monitored pullets (21 CFR 118.4(a)(1)) and environmental testing of pullets at 14-16 weeks (21 CFR 118.4(a)(2)). 2. **Insufficient Biosecurity:** No written measures to prevent SE introduction/transfer (21 CFR 118.4(b)), with observed gaps in poultry houses and missing/unsecured fan cages. 3. **Inadequate Pest Control:** Failure to monitor rodents with thresholds or corrective actions (21 CFR 118.4(c)(1)), with observed rodent activity. 4. **Missing Cleaning/Disinfection Procedures:** SE Prevention Plan lacked procedures