FDA WARNING_LETTER - Martin, Marlin - February 13, 2014

On January 13, 24, and February 13, 2014, the FDA inspected Martin, Marlin's dairy operation. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on June 11, 2013, was found to have 12.07 ppm of desfuroylceftiofur in kidney tissue, exceeding the 0.4 ppm tolerance for ceftiofur, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, failing to maintain complete treatment records and to identify and segregate treated animals, leading to adulterated food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug Naxcel (ceftiofur sodium sterile powder) was adulterated due to extralabel use not in compliance with 21 C.F.R. Part 530. Specifically, Naxcel was administered without following approved labeling indications or frequency, and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a). Extralabel use of Naxcel in cattle is prohibited by 21 C.F.R. 530.41