Company
United StatesEntellus Medical Inc., Plymouth, MN – FDA Inspections
Inspection records and compliance data for Entellus Medical Inc. in Plymouth, Minnesota. 3 FDA inspections on record (1 OAI), last inspected September 27, 2016.
Company Profile
This profile covers Entellus Medical Inc. based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 20, 2012. Last inspected September 27, 2016.
Most cited issue areas
- No approval for changes requiring prior approval1 inspection
- Sponsor securing investigator compliance1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2016 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 988574 |
| May 28, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 929623 |
| August 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 793684 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Entellus Medical Inc.
FEI Number
3006345872
Address
3600 Holly Ln N Ste 40, Plymouth, Minnesota 55447, United States
Country
United States
ID: 24921cd2-fbc6-4c0f-8825-a65a2ff5c5e2