FDA Inspection
Septodont Inc.Septodont Inc. – FDA Inspection, Aug 12, 2019
Record Details
This FDA Inspection record concerns Septodont Inc., with an inspection on August 12, 2019, issued by the Denver District Office, covering human drugs.
- Office
- Denver District Office
- People
- Jamie L. Dion (Issuing Officer)
- Zachary L. Stamm (FDA Associated Person)
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ID · 4abbbd2b-03fa-49d5-94b7-6ae9a41cac11
Inspection Facts
- Inspection number
- 1099419
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Septodont Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2018 | VAI | Denver District Office | Generic Drug Evaluation |
| November 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 19, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Septodont Inc.
- FDA Inspection 1120878 - 2020-02-10
- FDA Inspection 1076290 - 2018-12-21
- FDA Inspection 1032021 - 2017-11-22
- FDA Inspection 885442 - 2014-05-19
- FDA Inspection 835523 - 2013-06-12
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