FDA WARNING_LETTER - InSight Dairy, LLC. - January 06, 2010

On January 4 and 6, 2010, the FDA inspected InSight Dairy, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale adulterated animals for slaughter. Specifically, on July 19, 2010, a bob veal calf sold for slaughter contained 12.95 ppm of neomycin residue in the kidney, exceeding the 7.2 ppm tolerance. On August 2, 2010, another bob veal calf sold for slaughter had 10.53 ppm of neomycin in the kidney. The tolerance does not apply to the use of the medicated milk replacer in bob veal calves, and there is no acceptable residue level for this use. This constitutes adulteration under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed 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, violating 21 U.S.C. § 342(a)(4). Furthermore, the firm adulterated the new animal drug neomycin sulfate by using it extralabelly in feed for bob veal calves, violating 21 C.F.R. 530.11(b) and (c), and causing the drug and feed to be unsafe and