FDA inspection
USHIO GERMANY GmbH: FDA inspection ending Aug 23, 2019
FDA inspection 1100385 · Official Action Indicated (OAI) · Steinhoring
Key facts
| Inspection ID | 1100385 |
|---|---|
| Firm | USHIO GERMANY GmbH |
| FEI number | 3425 |
| Address | Munchener Str. 10 |
| City | Steinhoring |
| Country | Germany |
| Fiscal year | 2019 |
| Inspection end date | Aug 23, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 596106 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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