FDA Inspection 1032161 — STARS MICROELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED
The FDA completed an inspection of STARS MICROELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED on Nov 16, 2017 in Bang Pa-In. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 16, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bang Pa-In (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3159 | 21 CFR 820.184 | DHR content |