The United States Enters Consent Decree of Permanent Injunction
Sterile Drug Products in Violation of Current Good Manufacturing Practice Requirements
On Jan. 8, 2016, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.
According to the complaint filed with the consent decree, Downing Labs (formerly known as NuVision Pharmacy) manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA pursued appropriate and aggressive action to protect the public health.”
The U.S. Department of Justice brought the action on behalf of the FDA. The consent decree prohibits Downing Labs and its owners from manufacturing, holding or distributing drugs until they comply with the FD&C Act and its regulations, in addition to other requirements.
Last Updated: 2016-01-11