FDA 483 - IOI OLEO GMBH - January 17, 2020

IOI OLEO GMBH, a drug substances manufacturer in Witten, Germany, was inspected and cited for significant deficiencies across multiple areas. Observations included inadequate complaint investigations, failure to calibrate manufacturing equipment, improper identification and control of drug substance containers and raw materials, and an incomplete employee training program. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.