FDA WARNING_LETTER - Durst Brothers, Inc. - December 07, 2010

On December 6-7, 2010, the Minnesota Department of Agriculture inspected Durst Brothers, Inc. in Mantorville, Minnesota, leading to this Warning Letter addressed to Rolland E. Durst, Dairy Manager/Partner. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act, specifically the adulteration of new animal drugs penicillin G procaine and tilmicosin injection. The firm engaged in extralabel use of these drugs, failing to follow approved labeling directions. For penicillin G procaine, the drug was administered without adhering to the stated dose, and its extralabel use lacked the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). Similarly, tilmicosin injection was administered to a dairy cow 20 months or older, a use not approved per 21 CFR 522.2471, and its extralabel application also occurred without licensed veterinarian supervision, again violating 21 CFR 530.11(a). These actions rendered the drugs unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act. Durst Brothers is responsible for ensuring overall compliance and must take prompt corrective action to prevent recurrence. A written response detailing corrective steps, including documentation, is required within 15 working days. Failure to comply may result in regulatory actions like seizure or injunction.