As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
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In an Oct. 25 warning letter the Food and Drug Administration outlined problems found at Granja Asomante, Road 569 Km 5.5 Interior, Orocovis 00720, Puerto Rico. Some of the key findings in the letter are as follows.
On April 15, 2025, through May 1, 2025, the U.S. Food and Drug Administration conducted an inspection of your shell egg farm. During the inspection of your farm, FDA investigators observed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs during production, storage and transportation regulation (the Shell Egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Failure to comply with the provisions of 21 CFR Part 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the deviations found at your farm. We received your written response to the FDA-483 on May 20, 2025, describing corrective actions taken. We are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your farm.