FDA inspection
Ambu A/S: FDA inspection ending Sep 11, 2019
FDA inspection 1136851 · Voluntary Action Indicated (VAI) · Ballerup
Key facts
| Inspection ID | 1136851 |
|---|---|
| Firm | Ambu A/S |
| FEI number | 3002806359 |
| Address | Baltorpbakken 13 |
| City | Ballerup |
| Fiscal year | 2019 |
| Inspection end date | Sep 11, 2019 |
| 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