During an inspection of Qualgen’s facility in Edmond, Oklahoma, FDA investigators observed “insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced,” said the agency.
The FDA recommended the company cease sterile operations until it fixed the problems, but Qualgen agreed only to voluntarily recall 67 lots of drugs. The recalled products were compounded before September 1, 2015 and have not yet expired.
The Food and Drug Administration said it is not aware of any adverse events associated with Qualgen’s products, but warned:
“Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Qualgen or Amerilab LLC, the facility’s former name, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.”
Under the November 2013 Drug Quality and Security Act, which added section 503B to the Federal Food, Drug, and Cosmetic Act (FDCA), outsourcing facilities must comply with current good manufacturing practice requirements, are subject to inspection by FDA according to a risk-based schedule; and must report adverse events and provide the FDA with information about the products they compound.
The FDA tightened up rules this year on the circumstances under which compounding pharmacies must register as outsourcing facilities.