FDA WARNING_LETTER - De Groot Sheep Inc - March 16, 2012

On March 14-16, 2012, the FDA inspected De Groot Sheep Inc. in Orange City, Iowa, and found violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed the adulteration of the new animal drug fenbendazole, contained in a customized medicated feed ration fed to lambs.

Specifically, the company used SAFE-GUARD .5% (fenbendazole) (Swine\Beef\Dairy\Horse Dewormer) in a Type C Medicated Feed for lambs, which is an extralabel use not in accordance with the drug's approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. § 530.11(a) and 21 C.F.R. Part 530. This rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

Additionally, the company adulterated SAFE-GUARD .5% (fenbendazole) Type B Medicated Feed by failing to use it in conformance with its approved labeling, specifically regarding the animal species. The extralabel use of medicated feeds is not permitted under 21 C.F.R. 530.11(b) and section 512 of the FD&C Act, causing the