FDA WARNING_LETTER - Reliance Dairy LLC - September 16, 2015

On September 8-16, 2015, the FDA inspected Reliance Dairy, LLC, finding violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on January 8, 2015, was found to be adulterated. USDA/FSIS analysis of kidney tissue from this animal, slaughtered on January 9, 2015, revealed desfuroylceftiofur (ceftiofur marker residue) at 2.34 ppm, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Reliance Dairy held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain complete treatment records. This is adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the drug (b)(4) (Ceftiofur Crystalline Free Acid) Sterile Suspension, NADA (b)(4), was adulterated. Reliance Dairy used this drug extralabelly, administering it to a dairy cow without following approved labeling indications or the meat withdrawal period. This extralabel use was not under licensed veterinarian supervision, violating