FDA Inspection
Teoxane S.A.Teoxane S.A. – FDA Inspection, Nov 16, 2012
Record Details
This FDA Inspection record concerns Teoxane S.A., with an inspection on November 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Teoxane S.A.
- Inspection Date
- November 16, 2012
- Product Type
- Devices
View Company Profile
ID · 0d041736-d063-41e6-ae57-7d5ad3d801c4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 806598
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 812.150(b)(7)30-day sponsor notification to FDA
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
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Other FDA inspections of Teoxane S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2018 | Not classified | Office of Inspections and Investigations | |
| June 29, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Teoxane S.A.
- FDA Inspection 1120148 - 2018-10-11
- FDA Inspection 1044275 - 2017-06-29
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