FDA Inspection
Septodont Inc.Septodont Inc. – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Septodont Inc., with an inspection on December 21, 2018, issued by the Denver District Office, covering human drugs.
- Office
- Denver District Office
- Person
- Jamie L. Dion (Issuing Officer)
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ID · 98eed30b-6e04-4397-93f9-e977c2586e99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076290
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 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 |
| August 12, 2019 | Not classified | 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 1099419 - 2019-08-12
- FDA Inspection 1032021 - 2017-11-22
- FDA Inspection 885442 - 2014-05-19
- FDA Inspection 835523 - 2013-06-12
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