FDA inspection
Draeger Medical Systems, Inc.: FDA inspection ending Sep 20, 2019
FDA inspection 1109645 · Official Action Indicated (OAI) · Andover, MA
Key facts
| Inspection ID | 1109645 |
|---|---|
| Firm | Draeger Medical Systems, Inc. |
| FEI number | 3005783425 |
| Address | 6 Tech Dr |
| City | Andover |
| State | MA |
| ZIP | 01810 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Sep 20, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 596529 |
At a glance
- None 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