Nestor Reyes Farm & Associates Inc. – FDA Warning Letter, Dec 6, 2024

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Nestor Reyes Farm & Associates following inspections conducted on November 13-15, 19, and December 6, 2024, at their shell egg farm and processing facility in Rio Grande, 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).

The primary violation was the company"s failure to develop and implement a comprehensive written SE Prevention Plan. Specific issues included inadequate documentation for pullet procurement, absence of required SE environmental testing for pullet flocks at 14-16 weeks of age, and significant biosecurity deficiencies. Investigators observed unrestricted visitor access, structural damage to poultry houses allowing entry of wild birds, cats, and reptiles, and a general lack of practices to prevent cross-contamination. Furthermore, the farm failed to implement adequate rodent, fly, and pest control measures, including proper monitoring and removal of debris providing pest harborage.

These failures render the company"s shell eggs non-compliant with 21 CFR Part 118, violating section 361(a) of the Public Health Service Act, and adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

While the company submitted a response detailing some corrective actions like visitor restriction and structural repairs by June 2025, the FDA deemed it lacking in detail and still requires the submission of a finalized, comprehensive written SE Prevention Plan. Nestor Reyes Farm & Associates must take prompt and thorough action to address all identified violations and provide documented evidence of full compliance.