FDA Inspection 1049530 — Dragon Heart Medical Inc.
The FDA completed an inspection of Dragon Heart Medical Inc. on April 24, 2018 in Elmhurst, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elmhurst, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |