FDA WARNING_LETTER - Humpty Dumpty Eggs, Inc - July 27, 2011

On November 15, 2011, the FDA issued a Warning Letter to Humpty Dumpty Eggs, Inc. following an inspection from July 25-27, 2011. 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 their shell eggs adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Absence of a written SE prevention plan:** The firm lacked a comprehensive written SE prevention plan as required by 21 CFR 118.4. While the firm stated they would begin writing one, a completed plan was not provided for evaluation. 2. **Inadequate rodent monitoring:** The firm failed to implement appropriate rodent monitoring methods (21 CFR 118.4(c)(1)). Mouse traps were improperly placed, and rodent bait/trap placement maps did not accurately reflect actual locations. The firm's response lacked details on their monitoring procedures and corrective actions for unacceptable rodent activity. 3. **Failure to perform environmental SE testing:** Environmental testing for SE was not conducted when laying hens reached 40-45 weeks of age (21 CFR 118.5(a)). No environmental testing had been performed since the regulation's compliance date of July 9, 2010.