Septodont Inc.August 12, 2019

FDA 483 - Septodont Inc. - August 12, 2019

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Record Details

An FDA inspection of Sagent-dont Inc., a drug manufacturer in Louisville, CO, revealed significant deficiencies in their quality system. Observations included inadequate deviation investigations, poor laboratory control mechanisms, and failures to follow written production and process control procedures. One critical observation regarding deviation investigations was a repeat from a previous inspection.

Company: Septodont Inc.
Inspection Date: August 12, 2019
Product Type: Drugs
Office: Denver District Office
People: Zachary L. Stamm (Pharmaceutical Program Expert)
Jamie Dion (Consumer Safety Officer)

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ID · 86fbf988-8995-4c8e-8645-8a3874509447