FDA inspection
Rolence Ent. Inc.: FDA inspection ending Jul 11, 2024
FDA inspection 1245614 · Official Action Indicated (OAI) · Chungli
Key facts
| Inspection ID | 1245614 |
|---|---|
| Firm | Rolence Ent. Inc. |
| FEI number | 3002772487 |
| Address | No. 18-3, Lane 231 Pu Chung Road |
| City | Chungli |
| Country | Taiwan |
| Fiscal year | 2024 |
| Inspection end date | Jul 11, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 695010 |
At a glance
- 10–99 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