FDA Inspection
BioSphere Medical S.A.BioSphere Medical S.A. – FDA Inspection, Jun 16, 2016
Record Details
This FDA Inspection record concerns BioSphere Medical S.A., with an inspection on June 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioSphere Medical S.A.
- Inspection Date
- June 16, 2016
- Product Type
- Devices
View Company Profile
ID · 8e5884da-1b39-452b-ab1a-6311bf120494
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 978525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioSphere Medical S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | Not classified | Office of Inspections and Investigations | |
| 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 1134765 - 2018-08-03
- FDA Inspection 756570 - 2011-12-01
- FDA Inspection 592355 - 2009-06-19
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