FDA WARNING_LETTER - Raber View Holstein - August 09, 2010

On August 3 and 9, 2010, the FDA investigated Raber View Holstein's dairy operation in Millersburg, Ohio, and found violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on January 7, 2010, contained 0.829 ppm of sulfamethoxazole in muscle and 0.484 ppm in liver, making the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii) as FDA has no tolerance for this drug in cattle.

The operation also 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 treatment records. This constitutes adulteration under 21 U.S.C. § 342(a)(4).

Furthermore, the firm adulterated the new animal drug sulfamethoxazole and trimethoprim (800 mg/160 mg per tablet) by using it extralabelly without following approved labeling or veterinarian's directions, and without veterinary supervision, violating 21 C.F.R. 530.11(a) and (c). This extralabel use resulted in an illegal drug residue, making the drug unsafe and adulterated under 21 U.S.C. § 351