FDA Inspection 896796 — Dragon Heart Medical Devices Co., Ltd.
The FDA completed an inspection of Dragon Heart Medical Devices Co., Ltd. on August 14, 2014 in Kaiping. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kaiping (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |