FDA Inspection 734089 — Vatech Co., Ltd.
The FDA completed an inspection of Vatech Co., Ltd. on Jun 10, 2011 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Hwaseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5468 | 21 CFR 1020.30(j) | Mandatory warning on control panel |