FDA inspection
BioSphere Medical S.A.: FDA inspection ending Aug 3, 2018
FDA inspection 1134765 · Voluntary Action Indicated (VAI) · Roissy En France
Key facts
| Inspection ID | 1134765 |
|---|---|
| Firm | BioSphere Medical S.A. |
| FEI number | 3002808761 |
| Address | Batiment A-Parc Des Nations-Paris Nord 2, 383 Rue De La Belle Etoile |
| City | Roissy En France |
| Fiscal year | 2018 |
| Inspection end date | Aug 3, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data