FDA inspection
Sunder Biomedical Tech Co., Ltd.: FDA inspection ending Sep 13, 2017
FDA inspection 1026110 · Official Action Indicated (OAI) · Yunlin
Key facts
| Inspection ID | 1026110 |
|---|---|
| Firm | Sunder Biomedical Tech Co., Ltd. |
| FEI number | 3003656001 |
| Address | Pao-Chung Hsiang, No. 16 Chung-Chen Rd. Dung Ming Village |
| City | Yunlin |
| Country | Taiwan |
| Fiscal year | 2017 |
| Inspection end date | Sep 13, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 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