FDA Inspection
Entellus Medical Inc.Entellus Medical Inc. – FDA Inspection, Sep 27, 2016
Record Details
This FDA Inspection record concerns Entellus Medical Inc., with an inspection on September 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Entellus Medical Inc.
- Inspection Date
- September 27, 2016
- Product Type
- Devices
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ID · f8bdb763-c5b3-4020-8c90-3819ff4f11b1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 988574
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.35(a)(1)No approval for changes requiring prior approval
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Other FDA inspections of Entellus Medical Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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