FDA Inspection
BioSphere Medical S.A.BioSphere Medical S.A. – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns BioSphere Medical S.A., with an inspection on August 3, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- BioSphere Medical S.A.
- Inspection Date
- August 3, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 60b3f498-104a-462a-89b4-8baa75d3f9e7
Inspection Facts
- Inspection number
- 1134765
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of BioSphere Medical S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 1, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 19, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioSphere Medical S.A.
- FDA Inspection 978525 - 2016-06-16
- FDA Inspection 756570 - 2011-12-01
- FDA Inspection 592355 - 2009-06-19
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