FDA inspection
Ortho Clinical Diagnostics Gmbh: FDA inspection ending Feb 12, 2015
FDA inspection 917103 · Official Action Indicated (OAI) · Neckargemund
Key facts
| Inspection ID | 917103 |
|---|---|
| Firm | Ortho Clinical Diagnostics Gmbh |
| FEI number | 3001665564 |
| Address | Karl-Landsteiner-Str. 1 |
| City | Neckargemund |
| Country | Germany |
| Fiscal year | 2015 |
| Inspection end date | Feb 12, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 457877 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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