Loyd Sanabria Hernandez – FDA Warning Letter, May 15, 2024

On December 17, 2024, the FDA issued a Warning Letter to Loyd Sanabria Hernandez, owner of a shell egg farm and processing facility in Salinas, Puerto Rico, following an inspection from April 29 to May 15, 2024. 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 the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate SE Prevention Plan (21 CFR 118.4):** The written plan, "Protocolo de Bioseguridad de Avicola Santa Fe-Medidas Sanitarias y Preventivas," was deficient. * **Pullets:** Failed to include requirements for SE-monitored pullets or environmental testing at 14-16 weeks of age. Neither flock in Ranch #1 nor Ranch #2 was tested. * **Biosecurity:** Lacked adequate measures to prevent SE introduction/transfer. Disinfection points were not implemented (e.g., Ranch (b)(4) lacked a footbath), and equipment cleaning frequency was insufficient. * **Pest Control:** No written procedures for monitoring rodents or flies, lacked thresholds for acceptable activity, and failed to remove debris/vegetation providing harborage.