FDA WARNING_LETTER - Machia and Sons Dairy, LLC - July 08, 2013

On June 28 and July 8, 2013, the FDA inspected Machia & Sons Dairy, LLC, finding multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on January 28, 2013, was found to have sulfamethoxazole in its kidney tissue, for which FDA has no tolerance in calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically 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 adulterated the human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, by using it extralabelly without following the prescribed withdrawal period or licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and (c), and resulting in an illegal drug residue. This rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5).

Additionally, the firm adulterated animal feed by adding the human drug to milk replacer