FDA WARNING_LETTER - Robert G. Miller - May 01, 2025

The FDA issued a Warning Letter to Robert G. Miller dba Granja Asomante following an inspection from April 15, 2025, to May 1, 2025, at their shell egg farm in Orocovis, Puerto Rico. 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) and the Federal Food, Drug, and Cosmetic Act. These violations render the company"s shell eggs adulterated due to insanitary conditions. Key issues included the failure to adequately implement a written SE prevention plan. Specifically, the company did not procure chicks from SE-monitored breeder flocks as required, tested pullet environments outside the specified age range, and exhibited significant biosecurity lapses. These lapses involved inadequate footbath practices for personnel, lack of proper footbath maintenance, and the presence of wild birds and cats, along with unsealed entry points, in hen houses. Furthermore, the company"s rodent control monitoring was deemed insufficient, with unclear corrective actions for documented pest activity. While Robert G. Miller dba Granja Asomante submitted corrective actions, the FDA expressed continuing concerns, stating that the implementation and adequacy of these actions will be verified during subsequent inspections. The company must ensure full compliance to address these regulatory deficiencies.