FDA Inspection
BioSphere Medical S.A.BioSphere Medical S.A. – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns BioSphere Medical S.A., with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioSphere Medical S.A.
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · 9ebf7555-8a87-4326-8ba6-9387557dc3ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756570
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of BioSphere Medical S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | Not classified | Office of Inspections and Investigations | |
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 19, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioSphere Medical S.A.
- FDA Inspection 1134765 - 2018-08-03
- FDA Inspection 978525 - 2016-06-16
- FDA Inspection 592355 - 2009-06-19
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