The consent decree concerns Downing Labs (which was once called NuVision Pharmacy). The legal action claims the company manufactured and sold pharmaceutical medications, labelled as sterile, when in fact the drugs were adulterated. The adulteration relates to the manufacturing environment being assessed by the U.S. Food and Drug Administration (FDA) as “unsanitary” and not meeting the requirements of Good Manufacturing Practice (GMP).
Longstanding readers of Digital Journal may recall the case. Back in April 2013, we reported
That NuVision Pharmacy was recalling selected products, such as methylcobalamin injection, due to a lack of sterility assurance, which related to weak quality control processes. This was in the context of a number of compounding pharmacy units being cited for GMP issues. The trigger for the investigation was medical reports from clinicians who had noticed unusual reactions when certain products had been administered by injection.
The FDA issued its final report on NuVision in July 2014. This detailed various violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A further FDA inspection in October 2015, led to the company (now rebranded as Downing Labs) initiating a further voluntary recall.
Speaking on the action, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research stated: “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.” On this basis Woodcock adds “the FDA pursued appropriate and aggressive action to protect the public health.”
The case against the manufacturer has been taken on behalf of FDA by the U.S. Department of Justice. The consent decree, passed by Justice Lindsay prohibits Downing Labs from manufacturing, holding or distributing drugs until they comply with the FD&C Act.
Digital Journal has run a series of investigative articles on the problems facing U.S. compounding pharmacies as the U.S. Food and Drug Administration (FDA) embarks on a series of inspections into issues of quality and sterility of medicines.
