Animal & Veterinary
Clarification -- Consent Decree Entered in Animal Drug CGMP Case
April 7, 1999
The following is a clarification of a CVM UPDATE issued 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., is located in Berlin Center, Ohio. Only a limited portion of Berlin's business involved the manufacture of animal drugs.
The Complaint for Permanent Injunction filed by the government alleged that Berlin Industries violated current good manufacturing practice regulations (21 CFR 211) for finished pharmaceuticals and that the firm engaged in manufacturing and distributing unapproved new animal drugs intended for use in horses.
The U.S. Department of Justice, FDA, and Berlin negotiated a Consent Decree for Permanent Injunction in which the firm neither admitted nor denied the allegations, and opted to settle the case. In this Consent Decree the firm agreed to voluntarily discontinue manufacturing, processing, packing, or labeling of 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.
The FDA's Cincinnati District Office conducted all investigative work for this case. The CVM's Division of Compliance, the 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.