FDA inspection
BioSphere Medical S.A.: FDA inspection ending Jun 16, 2016
FDA inspection 978525 · Voluntary Action Indicated (VAI) · Roissy En France
Key facts
| Inspection ID | 978525 |
|---|---|
| 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 |
| Country | France |
| Fiscal year | 2016 |
| Inspection end date | Jun 16, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 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