Animal & Veterinary
Consent Decree Entered in Animal Drug CGMP Case
December 15, 1998
On November 30, 1998, a U.S. District Court Judge for the Northern District of Ohio, Eastern Division, incorporated into an order the entry of a Consent Decree for Permanent Injunction between the United States, and Berlin Industries, Inc., William J. Barnett (President) and Robert R. Roth (General Manager). Berlin Industries, Inc., an animal drug manufacturer, is located in Berlin Center, Ohio. The firm has a long history of violating current good manufacturing practice regulations (CGMPs; 21 CFR 211) for finished pharmaceuticals. In addition, the firm was engaged in manufacturing and distributing unapproved new animal drugs intended for use in horses.
Under the terms of the Consent Decree, Berlin Industries, Mr. Barnette, and Mr. Roth agreed to discontinue manufacturing, processing, packing, or labeling any drugs and/or distributing unapproved new animal drugs. It was also agreed that the firm will surrender its drug establishment registration. The firm may not re-enter the business of manufacturing, processing, packing, or labeling any drugs, unless it re-registers with FDA and implements any measures that FDA may deem necessary to prevent future violations of the Federal Food, Drug, and Cosmetic Act. Violation of this Consent Decree may carry civil or criminal penalties. FDA's Cincinnati District Office conducted all investigative work for this case. CVM's Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Department of Justice's Office of Consumer Litigation were in charge of the case processing and litigation.