FDA WARNING_LETTER - T & S Dairy - January 09, 2020

The FDA conducted an investigation of Mrs. De Boer's dairy operation in Winnsboro, TX, on December 9, 2019, and January 9, 2020. The inspection revealed conditions where medicated animals with potentially harmful drug residues were likely to enter the food supply, rendering food from these animals adulterated under 21 U.S.C. § 342(a)(4). Key violations included a failure to maintain adequate treatment records. Furthermore, the firm adulterated animal drugs, specifically penicillin G procaine and flunixin meglumine, through extralabel use. The investigation found these drugs were not used as directed by their approved labeling. Instances included administering incorrect dosages (40 ml penicillin G procaine and 20 ml flunixin meglumine) and treating for unapproved indications (lameness) for both drugs. Crucially, this extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), which rendered the drugs unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). The firm was also notified by USDA/FSIS of selling a cow with penicillin and flunixin residues above established tolerances. Mrs. De Boer is required to take prompt corrective action, establish procedures to prevent recurrence, and respond to the FDA in writing within fifteen working days, detailing steps taken or planned, with supporting documentation. Failure to comply may result in regulatory actions such as seizure or injunction.