U.S. District Court Enters Permanent Injunction to Prevent Dallas Compounding Pharmacy and Three Individuals from Distributing Adulterated Drugs in Texas.
The U.S. District Court for the Northern District of Texas entered a consent decree for permanent injunction against Downing Labs LLC, Ashley Michelle Downing, Christopher Van Downing, and Roger E. Mansfield to prevent them from distributing adulterated drugs in interstate commerce, the U.S. Food and Drug Administration (FDA) announced today. The permanent injunction was filed January 4, 2016.
The FDA complaint alleged that Downing Labs manufactures, packs, labels, and distributes drugs in interstate commerce. The complaint also alleged that Downing Labs has been engaged in manufacturing drugs that, by virtue of their labeling and/or route of administration, purport to be or are intended to be sterile. The complaint stated that Downing Labs has a long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality.
“The permanent injunction requires Downing Labs and the individual defendants to bring their processes into compliance with the law, which is essential to ensuring that Downing Labs’ drug products are safe for the American public,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will remain vigilant in protecting consumers from pharmaceutical drugs that do not meet the safety protections provided under federal law.”
The federal Food, Drug, and Cosmetic Act defines adulterated drugs as those that are prepared or held under conditions where the drugs may become contaminated with filth or may become injurious to health. The Act also defines drugs as adulterated if the facilities or controls used for the drugs’ manufacture are not in conformity with current good manufacturing practices (CGMP).
The complaint alleged, among other things, that Downing Labs, its owners – Ashley and Christopher Downing – and pharmacist-in-charge, Roger E. Mansfield, violate the Act by introducing or delivering for introduction into interstate commerce sterile drugs that are adulterated in that they are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth and/or rendered injurious to health. The complaint also alleged that defendants violate the Act by introducing or delivering for introduction into interstate commerce drugs that are adulterated in that the methods used in, or the facilities or controls used for, their preparation do not comply with CGMP requirements.
The complaint alleged that the FDA conducted multiple inspections of Downing Labs and its predecessor, NuVision Pharmacy Inc. (NuVision), during the past three years. These inspections revealed numerous deficiencies, many of which had to do with the firm’s sterile drug production. The complaint alleged, for example, that test records obtained from the company pursuant to a September to October 2015 inspection showed excessively high levels of endotoxins in recently manufactured drug products. These products were not distributed. Endotoxins are substances found in certain bacteria that can cause a wide variety of serious reactions in humans, including high fever and shock.
Defendant: Downing Labs LLC, Ashley Michelle Downing, Christopher Van Downing, Roger E. Mansfield
Criminal Charges: Distributing adulterated drugs in interstate commerce
City and State: Dallas, Texas
Date: January 4, 2016
Sentence or Outcome: Permanent injunction
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Key Facts
- State: Texas
- Category: Drug Trafficking
- Source: DOJ Press Release â†â€â€
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