FDA inspection
Visgeneer, Inc.: FDA inspection ending Feb 27, 2025
FDA inspection 1264311 · Official Action Indicated (OAI) · Hsinchu City
Key facts
| Inspection ID | 1264311 |
|---|---|
| Firm | Visgeneer, Inc. |
| FEI number | 3005644014 |
| Address | No. 335 Zhong Hua Rd., Sec. 6, Xiangshan Dist. |
| City | Hsinchu City |
| Country | Taiwan |
| Fiscal year | 2025 |
| Inspection end date | Feb 27, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 709010 |
At a glance
- None 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