Company
FranceBioSphere Medical S.A., Roissy En France, France – FDA Inspections
Inspection records and compliance data for BioSphere Medical S.A. in Roissy En France. 4 FDA inspections on record, 1 Form 483, last inspected August 03, 2018.
Company Profile
This profile covers BioSphere Medical S.A. based in Roissy En France, France.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 19, 2009. Last inspected August 3, 2018.
Most cited issue areas
- Design validation - documentation1 inspection
- Design verification - documentation1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 3, 2018 | Not classified | Medical Devices & Rad Health | 1134765 |
| June 16, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 978525 |
| December 1, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 756570 |
| June 19, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 592355 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BioSphere Medical S.A.
FEI Number
3002808761
Address
Batiment A-Parc Des Nations-Paris Nord 2, 383 Rue De La Belle Etoile, Roissy En France, France
Country
France
ID: 40a5f60c-6a3b-4223-8297-5b15b0fc462f