FDA 483 - American Regent Inc. - July 26, 2019

American Regent Inc. in Hilliard, OH, a drug manufacturer, was cited for failing to adequately investigate out-of-specification stability results for a distributed drug batch. The inspection also revealed that the firm did not follow its own written production and process control procedures. This included deficiencies in biennial SOP reviews and documentation of cleaning activities in the sterile manufacturing plant.