FDA Inspection 952986 — Rochester General Hospital
The FDA completed an inspection of Rochester General Hospital on Dec 9, 2015 in Rochester, NY. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |