Company
United StatesInovise Medical, Inc., Beaverton, OR – FDA Inspections
Inspection records and compliance data for Inovise Medical, Inc. in Beaverton, Oregon. 3 FDA inspections on record, last inspected June 12, 2015.
Company Profile
This profile covers Inovise Medical, Inc. based in Beaverton, Oregon, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 1, 2011. Last inspected June 12, 2015.
Most cited issue areas
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Lack of or inadequate procedures for storage.1 inspection
- Quality audits - auditor independence1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 933856 |
| March 21, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823440 |
| June 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 727390 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Inovise Medical, Inc.
FEI Number
3003264460
Address
8770 SW Nimbus Ave Ste D, Beaverton, Oregon 97008, United States
Country
United States
ID: fd7e0066-9c0e-49fb-9bcf-e52d57df4102