FDA 483 - Septodont Inc. - December 21, 2018

An FDA inspection of Septodont Inc. in Louisville, CO, a drug manufacturer, revealed that written records of investigations into unexplained discrepancies did not consistently include conclusions and follow-up actions. Specifically, several minor deviations were closed without the listed corrective actions being performed. This indicates a lapse in the firm's quality system regarding investigation closure and follow-through.