FDA WARNING_LETTER - Ray Souza Dairy - October 10, 2012

The FDA conducted an investigation of Souza Dairy in Chino, California, on August 14-15, August 27, and October 9-10, 2012, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the adulteration of the new animal drug (b)(4) (neomycin sulfate) (b)(4). This occurred because the dairy did not use the drug as directed by its approved labeling, specifically administering it to veal calves (ear tags (b)(4) and (b)(4)) without adhering to the specified animal class. This extralabel use was conducted without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Consequently, the drugs were rendered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act, as their use did not conform to approved labeling and 21 C.F.R. Part 530. Souza Dairy is required to take prompt corrective action to address these violations and implement procedures to prevent recurrence. A written response detailing these steps, including timelines and documentation, must be submitted to the FDA within fifteen working days. Failure to comply may lead to further regulatory actions, such as seizure or injunction.