FDA WARNING_LETTER - Mlsna Dairy Supply, Inc. - January 08, 2008

An FDA inspection of Mlsna Dairy Supply, Inc. on January 7-8, 2008, revealed significant violations concerning animal drug use and food adulteration. The firm offered an animal for slaughter with flunixin residues (0.128 ppm) exceeding the established tolerance (0.125 ppm) in the liver, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also found an inadequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal times, leading to potentially harmful drug residues entering the food supply, a violation of 21 U.S.C. § 342(a)(4). Specifically, treatment records were not maintained sufficiently. Furthermore, the firm adulterated new animal drugs, sulfadimethoxine and flunixin meglumine, under 21 U.S.C. § 351(a)(5) through extralabel use not conforming to approved labeling and 21 CFR Part 530. This included administering sulfadimethoxine without proper dosage, despite its prohibition for extralabel use in food-producing animals (21 CFR 530.41(a)(9)). Flunixin meglumine was administered without following the dosage period and without licensed veterinarian supervision (21 CFR 530.11(a)), resulting in an illegal drug residue (21 CFR 530.11(d)). Mlsna Dairy Supply must take prompt corrective action, establish preventative procedures, and respond within 15 working days, or face regulatory actions like seizure or injunction.