FDA inspection
Heartway Medical Products Co., Ltd.: FDA inspection ending Oct 27, 2011
FDA inspection 753535 · Official Action Indicated (OAI) · Taichung
Key facts
| Inspection ID | 753535 |
|---|---|
| Firm | Heartway Medical Products Co., Ltd. |
| FEI number | 3002847480 |
| Address | No. 6 Road, 25 Taichung Industrial Park |
| City | Taichung |
| Country | Taiwan |
| Fiscal year | 2012 |
| Inspection end date | Oct 27, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 270236 |
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