by Meghan Ross, Senior Associate Editor
Published Online: Monday, January 11, 2016
Compounding pharmacy Downing Labs (LLC), its co-owners, and its pharmacist-in-charge have been issued a consent decree of permanent injunction.
The Texas-based company is allegedly in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA stated in a press release.
Downing Labs is accused of manufacturing and distributing adulterated drugs that were made in insanitary conditions, meaning they were bad enough to endanger public health.
“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, in a press release. “The FDA pursued appropriate and aggressive action to protect the public health.”
Co-owners Ashley Michelle Downing and Christopher Van Downing and pharmacist-in-charge Roger E. Mansfield may not manufacture, hold, or distribute drugs until they comply with the FD&C Act and other requirements.
In October 2015, Downing Labs issued a recall of all lots of sterile products due to concerns with sterility assurance.
Some of the problems the FDA discovered were microbial contamination of injectable drug products, inadequate cleaning and sanitation of sterile processing areas, and inadequate sterile practices, in general.
Despite the fact that some of their products failed sterility testing, the FDA also found that Downing Labs distributed the products anyway.
There have been several other instances in which the company has been questioned about its quality control processes.
The FDA reported that the company recalled methylcobalamin injection and lyophilized injection products in April 2013 following patient reports of fever, flu-like symptoms, and soreness at the injection site.
The FDA also asked Downing Labs to issue a recall of all its sterile products in July 2013 and September 2014, but the company refused.
US District Judge Sam A. Lindsay entered the decree against the Texas-based company on January 8, 2016.
In a statement, Downing Labs said it has worked “collaboratively and cooperatively” with the FDA to reach an agreement that will enable it to resume the production of compounded sterile medication.
The compounder also noted that, as part of the consent decree, it voluntarily agreed to participate in a regular program of testing, audit, and inspection “to ensure it is achieving and exceeding its quality goals.”