Animal & Veterinary
CONSENT DECREE ENTERED IN ANIMAL DRUG CGMP CASE
FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V
On April 13, 1999, the U.S. District Court for the Western District of Wisconsin accepted and entered a Consent Decree of Permanent Injunction between the United States, and Radix Laboratories, Inc. and its President, Premchand Girdhari. Radix is a manufacturer of injectable animal drugs, as well as other dosage forms, located in Eau Claire, Wisconsin.
The government’s Complaint for Preliminary and Permanent Injunction alleged that, among other things, Radix manufactured veterinary drug products with significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. Under the Federal Food, Drug, and Cosmetic Act, a drug manufactured in violation of CGMP regulations is deemed adulterated.
Negotiations between the government and Radix resulted in a settlement in which the firm neither admitted nor denied the allegations of the complaint. In the Consent Decree of Permanent Injunction, the firm agreed to be restrained and enjoined from manufacturing, processing, packaging, labeling, holding and distributing drugs unless and until it is in compliance with the CGMP regulations. Radix has also agreed to hire an independent expert who will inspect the firm and certify in writing to the FDA that the firm is in compliance with the CGMP regulations. Further, the firm agreed to revise and correct any inaccuracies on the label of a product known as Multi-B Super. Violation of this consent decree may carry civil or criminal penalties.
FDA's Minneapolis 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, litigation and negotiation.