FDA WARNING_LETTER - Muxlow Dairy - February 05, 2013

On January 24, 29, and February 5, 2013, the FDA inspected Muxlow Dairy, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated dairy cow containing unsafe levels of amikacin in its kidney, violating 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, Muxlow Dairy held animals under insanitary conditions, including a failure to maintain complete treatment records, increasing the likelihood of drug residues entering the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). The firm also adulterated new animal drugs RVX Suppressor, FluMeglumine, and Ceftiflex through extralabel use, specifically by not adhering to approved labeling for withdrawal periods and duration of treatment. Crucially, this extralabel drug use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), rendering the drugs unsafe (21 U.S.C. 360b(a)) and adulterated (21 U.S.C. 351(a)(5)). The FDA acknowledged the firm's February 18, 2013, response but deemed it inadequate, particularly regarding ensuring medicated animals are not released within withdrawal times. Muxlow Dairy must take prompt corrective action and respond within fifteen working days, detailing steps to prevent recurrence, or face potential regulatory actions like seizure or injunction.