FDA Inspection 1284282 — Rolence Ent. Inc.
The FDA completed an inspection of Rolence Ent. Inc. on Sep 25, 2025 in Chungli. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chungli (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 5472 | 21 CFR 1020.30(k) | Compliance measurements--diagnostic source assembly |