FDA Inspection 970476 — Young Reem Electronics Co. Ltd
The FDA completed an inspection of Young Reem Electronics Co. Ltd on Apr 20, 2016 in Hwaseong. 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
- Apr 20, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Hwaseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 5705 | 21 CFR 1002.31(a) | Five year requirement |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |