483
Septodont Inc.FDA 483 - Septodont Inc. - December 21, 2018
Record Details
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.
- Office
- Denver District Office
- Person
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ID · 1fe57ad3-1f0d-4d3e-b7ee-52da3910c1bf