FDA Inspection
Obtech Medical SarlObtech Medical Sarl – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns Obtech Medical Sarl, with an inspection on June 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Obtech Medical Sarl
- Inspection Date
- June 11, 2015
- Product Type
- Devices
View Company Profile
ID · d3cdc731-91ac-4d04-ac1f-dd0351216d43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935309
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Obtech Medical Sarl
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 15, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Obtech Medical Sarl
- FDA Inspection 743980 - 2011-09-15
- FDA Inspection 563061 - 2009-01-15
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