Outsourcer Broke Rules for CGMP, Sterile Production, FDA Says
The FDA cited an outsourcing drug compounder in Arkansas for failure to meet sterile production standards, according to a warning letter from the agency.
The company, U.S. Compounding, of Conway, violated CGMP rules via failures in monitoring environmental conditions for aseptic processing, in designing its work spaces to prevent contamination, in laboratory testing of finished products and in investigation of out-of-specification products, the letter said.
FDA inspections in 2015 and 2016 also found violations of sterile production regulations that apply to all compounders and drugmakers, including an influx of poor quality air into the sterile workspace and unsealed, rough-cut holes and duct work in the workspace ceiling that could allow for contamination, the letter said.
U.S. Compounding is one of 73 outsourcing facilities registered under the Drug Quality and Security Act, a law passed in 2013 in response to the meningitis deaths of 76 individuals who were injected with contaminated drugs produced by New England Compounding Center (NECC) in Massachusetts. The 2013 law permits compounders to produce drugs that are not tied to individual patient prescriptions provided they register with the FDA as outsourcers. The registration subjects them to current good manufacturing practice regulations that do not apply to other compounders, who may produce drugs only for individual patient prescriptions.
NECC pharmacist Glenn Chin was convicted Oct. 25 of mail fraud and racketeering, but acquitted on murder charges; co-founder Barry Cadden received similar verdicts earlier in the year.
U.S. Compounding has resumed operations “after cessation of sterile operations and recall of sterile products,” the FDA said.