FDA Inspection 919512 — Stentys Inc.
The FDA completed an inspection of Stentys Inc. on February 26, 2015 in Princeton, NJ. 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
- February 26, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Princeton, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |