# FDA 483 - Septodont Inc. - December 21, 2018

Source: https://www.globalkeysolutions.net/records/483/septodont-inc/1fe57ad3-1f0d-4d3e-b7ee-52da3910c1bf

> FDA 483 for Septodont Inc. on December 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Septodont Inc.
- Inspection Date: 2018-12-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2019-08-12](https://www.globalkeysolutions.net/records/483/septodont-inc/86fbf988-8995-4c8e-8645-8a3874509447)

## Related Officers

- [Jamie L. C. Dion](https://www.globalkeysolutions.net/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.globalkeysolutions.net/companies/septodont-inc/eb4216fd-e7d3-4b75-b488-681239e138aa

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face