FDA Inspection 953430 — Dartmouth Hitchcock Medical Center
The FDA completed an inspection of Dartmouth Hitchcock Medical Center on December 17, 2015 in Lebanon, NH. 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
- December 17, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lebanon, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 640 | 21 CFR 803.18(a) | Event files -- failure to establish and maintain |
| 658 | 21 CFR 803.30(a)(2) | Report of Serious Injury Within 10 Days |