Texas Compounding Facility Ordered to Stop Manufacture and Distribution of Products

January 20, 2016

Topics: Compounding

Downing Labs, LLC, of Dallas, TX, is prohibited from manufacturing, holding, or distributing drugs under a consent decree of permanent injunction entered against the facility by a federal court. The consent decree was sought as a result of a Food and Drug Administration (FDA) inspection of the Downing Labs facility that revealed insanitary conditions and a violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act. For instance, FDA investigators determined Downing Labs distributed drug products that failed sterility testing, as reported in the agency’s news release. The company recalled all lots of compounded products on October 20, 2015.