FDA Inspection 952342 — New York Presbyterian Hospital Weill Cornell Medical Center
The FDA completed an inspection of New York Presbyterian Hospital Weill Cornell Medical Center on December 10, 2015 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 656 | 21 CFR 803.30(a)(1) | Report of Death Within 10 Days |