FDA Inspection 988574 — Entellus Medical Inc.
The FDA completed an inspection of Entellus Medical Inc. on September 27, 2016 in Plymouth, MN. 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
- September 27, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Plymouth, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14517 | 21 CFR 812.35(a)(1) | No approval for changes requiring prior approval |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |