FDA: Downing Labs Manufactured Injectable Drug Products in Unsanitary Conditions
A drug company that manufactured drug products in unsanitary conditions is prohibited from manufacturing, holding, or distributing drugs until they comply with federal regulations.
The U.S. Department of Justice filed the complaint against Downing Labs, its owners and pharmacist-in-charge on behalf of the Food and Drug Administration (FDA) following several investigations that found sterile drug products being manufactured in violation of federal law.
"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," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a written statement.
Prior to an April 2013 recall, the company – then NuVision Pharmacy – received reports that patients had experience fever, flu-like symptoms and soreness at the injection site after receiving methylcobalamin.
Following inspections in 2013 and 2014, the FDA formally requested that Downing Labs recall all of its unexpired sterile products on the market, and warned healthcare providers and consumers against their use.
Downing Labs refused and in June 2015 the company registered as an outsourcing facility.
After an FDA inspection in October 2015 that found serious deficiencies, the company conducted a nationwide recall and ceased operations. The FDA found microbial contamination of injectable drug products, inadequate cleaning and sanitization of sterile processing areas, and inadequate sterile practices. The investigation also found that the company distributing drug products that failed sterility testing.