FDA 483 - Immunex Rhode Island Corporation - April 19, 2019

An FDA inspection of Immunex Rhode Island Corporation (Amgen Rhode Island) in West Greenwich, RI, a drug substance manufacturer, identified four significant observations. These included inadequate procedures for investigating out-of-specification results, insufficient Quality Unit oversight of instrument calibration and maintenance, and failures in conducting adequate deviation investigations. Additionally, the Quality Unit lacked proper oversight over critical manufacturing steps, allowing unauthorized changes to parameters.