The FDA issued a 14-observation Form 483 to Irvine, California drugmaker Stason Pharmaceuticals for inadequate testing and other quality failures.
Agency investigators found that the facility reprocessed and released two lots of mercaptopurine, a cancer drug, without conducting final product testing.
The two lots had expiration dates of December 2018, but the firm lacked data to support their stability. Both lots failed to meet dissolution testing specifications, the agency said.
In addition, the quality unit failed to conduct an internal audit of manufacturing operations since September 2016, despite 21 lots of product failing stability testing from 2018 to 2019.