FDA inspection
AMBU Limited: FDA inspection ending May 20, 2016
FDA inspection 974130 · Voluntary Action Indicated (VAI) · Xia Men
Key facts
| Inspection ID | 974130 |
|---|---|
| Firm | AMBU Limited |
| FEI number | 3003924186 |
| Address | Xiang Yu F.T. Z., No. C Warehouse |
| City | Xia Men |
| Country | China |
| Fiscal year | 2016 |
| Inspection end date | May 20, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No 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