Justice Department prohibits Downing Labs from manufacturing drugs

The Department of Justice, on behalf of the Food and Drug Administration (FDA), filed a consent decree for permanent injunction against Dallas-based compounding pharmacy Downing Labs LLC late last week.

Downing Labs is alleged to have violated the Food, Drug and Cosmetic Act by making drug products in an unsterile environment. The drugs are considered adulterated because they could have become contaminated and thus potentially possess a health risk.

Under the injunction, Downing Labs, its co-owners and pharmacist-in-charge are prohibited from manufacturing, holding or distributing drugs until they comply with the act's current good manufacturing practices and other regulations.

“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,” FDA Center for Drug Evaluation and Research Director Janet Woodcock said. “The FDA pursued appropriate and aggressive action to protect the public health.”

The FDA has repeatedly raised concerns about Downing Labs' manufacturing practices based on its findings from numerous inspections of the company over the past three years. Its most recent inspection, which concluded in October, uncovered several serious problems such as microbial contamination of injectable drug products, and inadequate cleaning and sanitization of sterile processing areas. Additionally, the FDA found that products that failed sterility testing were still distributed by Downing Labs.

While Downing Labs did recall its sterile drug products in October, the company refused to recall the products when the FDA requested them to do so in July 2013 and September 2014.