FDA inspection
GaleMed Xiamen Co., Ltd.: FDA inspection ending Dec 12, 2013
FDA inspection 860665 · Official Action Indicated (OAI) · Xiamen
Key facts
| Inspection ID | 860665 |
|---|---|
| Firm | GaleMed Xiamen Co., Ltd. |
| FEI number | 3006783791 |
| Address | Amoy Export, 39 East Rd; Haicang |
| City | Xiamen |
| Country | China |
| Fiscal year | 2014 |
| Inspection end date | Dec 12, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 420390 |
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