Compounder Consent Decree

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In early January, a consent decree of permanent injunction was filed at FDA’s request by the U.S. Department of Justice against Dallas, Texas-based Downing Labs, formerly known as NuVision Pharmacy.  According to the complaint filed with the consent decree, Downing Labs manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of GMPs.  In July 2013 and September 2014, based on findings from FDA inspections ending in April 2013 and July 2014 respectively, FDA formally requested that Downing Labs recall all of its unexpired sterile products on the market, and warned health care providers and consumers against their use. Downing Labs refused the recall requests.  In June 2015, Downing Labs registered as an outsourcing facility. Most recently, as a result of serious deficiencies identified by FDA during an inspection ending in October 2015, the company conducted a nationwide recall of its purportedly sterile drug products due to a lack of sterility assurance, and it ceased sterile operations. The deficiencies included microbial contamination of injectable drug products, inadequate cleaning and sanitization of sterile processing areas, and inadequate sterile practices. FDA investigators also determined that the firm had distributed drug products that failed sterility testing.
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