FDA Inspection 842315 — Daheng New Epoch Technology, Inc.
The FDA completed an inspection of Daheng New Epoch Technology, Inc. on July 19, 2013 in Beijing. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Beijing (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |