FDA WARNING_LETTER - Corporacion Avicola Morovis Inc - March 14, 2024

The FDA issued a Warning Letter to Corporacion Avicola Morovis Inc. following an inspection of their shell egg farm and processing facility in Morovis, Puerto Rico, from January 11 to March 14, 2024. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118), rendering their shell eggs adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of a comprehensive SE Prevention Plan:** The farm did not have and implement a written SE Prevention Plan as required by 21 CFR 118.4. * **Biosecurity deficiencies (21 CFR 118.4(b)):** The plan failed to address preventing wild birds, stray poultry, cats, and other animals from entering poultry houses. Investigators observed a wild bird and unidentified animal excrement. Corrective actions were deemed inadequate, and proposed opening sizes for daily inspections were still concerning. * **Inadequate Rodent, Fly, and Pest Control (21 CFR 118.4(c)):** * **Rodent control (21 CFR 118.4(c)(1)):** The rodent control program lacked thresholds for acceptable bait consumption and corrective actions for unacceptable activity. Rodent fecal pellets were observed but not documented. The updated rodent index calculation