FDA WARNING_LETTER - Richard W. Weaver - June 03, 2015

On May 20 and June 3, 2015, the FDA inspected Richard W. Weaver's dairy operation in Deansboro, New York, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that an animal sold for slaughter on January 5, 2015, was adulterated, containing desfuroylceftiofur at 0.91 ppm in kidney tissue (tolerance 0.4 ppm) and flunixin at 0.251 ppm in liver tissue (tolerance 0.125 ppm), violating 21 U.S.C. §342(a)(2)(C)(ii). Furthermore, the firm held animals under inadequate conditions, such as failing to maintain treatment records and segregate treated animals, making it likely that medicated animals with harmful drug residues would enter the food supply, which adulterates food under 21 U.S.C. §342(a)(4). The new animal drugs (b)(4) (ceftiofur hydrochloride) and (b)(4) (flunixin meglumine) were also adulterated due to extralabel use. Specifically, (b)(4) was administered without following the dosage per injection site, and (b)(4) without following the approved route of administration. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal residues (21 C.F.R. 530.11(d)), rendering the drugs unsafe and adulterated per 21 U.S.C. §351(a)(5). The firm must take prompt corrective action within fifteen working days to address these violations and prevent recurrence, or face potential regulatory actions like seizure or injunction.