FDA WARNING_LETTER - Farriss Dairy Farms - July 22, 2011

On July 15 and 22, 2011, the FDA investigated Farriss Dairy Farms, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on January 13, 2011, contained 33.76 ppm of neomycin in kidney tissue, exceeding the 7.2 ppm tolerance and rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). This specific neomycin use is not permitted in female dairy cattle 20 months or older, meaning no acceptable residue level exists.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the firm engaged in extralabel use of neomycin sulfate (Neomycin Liquid) by administering it to a dairy cow without following approved labeling for the animal class. This extralabel use was not under the supervision of a licensed veterinarian (violating 21 C.F.R. 530.11(a)), resulted in an illegal drug residue (violating 21 C.F.R. § 530.11(c)), and was administered in or on feed