FDA WARNING_LETTER - Braaksma Partnership - October 18, 2012

The FDA conducted an inspection of Braaksma Partnership, dba B-3 Dairy, in Manhattan, Montana, from October 16-18, 2012. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act concerning the new animal drug SUPRA SULFA III (sulfamethazine). The firm was found to have adulterated the drug by not using it as directed by its approved labeling, constituting an extralabel use, which is generally allowed only under specific conditions by a licensed veterinarian within a valid veterinarian/client/patient relationship, as per 21 C.F.R. 530.3(a). Specifically, the dairy administered sulfamethazine to a lactating dairy cow, an action explicitly prohibited for extralabel use by 21 C.F.R. 530.41(a)(9). This non-conformance rendered the drug unsafe under Section 512(a) and adulterated under Section 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing corrective steps and timelines is due within fifteen working days to avoid potential regulatory actions like seizure or injunction. The firm is responsible for ensuring overall compliance with food safety laws.