# FDA 483 - Septodont Inc. - August 12, 2019

Source: https://www.globalkeysolutions.net/records/483/septodont-inc/86fbf988-8995-4c8e-8645-8a3874509447

> FDA 483 for Septodont Inc. on August 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Septodont Inc.
- Inspection Date: 2019-08-12
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2018-12-21](https://www.globalkeysolutions.net/records/483/septodont-inc/1fe57ad3-1f0d-4d3e-b7ee-52da3910c1bf)

## Related Officers

- [Jamie L. C. Dion](https://www.globalkeysolutions.net/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)
- [Pharmaceutical Program Expert](https://www.globalkeysolutions.net/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

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