FDA WARNING_LETTER - Brad Grate Dairy Farm - March 17, 2022

An FDA inspection of Brad Grate Dairy Farm, conducted in March 2022, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The farm offered an adulterated animal for slaughter, with kidney tissue containing desfuroylceftiofur residues at 2.59 ppm, exceeding the 0.4 ppm tolerance (21 CFR § 556.113(b)(1)(i)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. The farm also held animals under insanitary conditions, likely leading to drug residues in the food supply, violating section 402(a)(4). Specific deficiencies included failure to maintain complete and accurate treatment records (lacking route of administration, administrator identity, and consistent drug doses) and absence of a drug inventory system. Additionally, the farm engaged in extra-label drug use of (b)(4) and Ampicillin Trihydrate for unapproved conditions and without licensed veterinarian supervision, violating 21 CFR § 530.11(a). The drug (b)(4) was also adulterated by being administered via an unapproved route, violating 21 CFR § 530.41(a)(13)(ii). These actions caused drugs to be unsafe and adulterated under sections 512(a)(4), 512(a)(5), and 501(a)(5) of the FD&C Act. The FDA requires a written response within fifteen working days detailing corrective actions and prevention plans, warning of potential legal action like seizure or injunction if unaddressed.