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.