Company
United StatesAbleNet, Inc., Roseville, MN – FDA Inspections
Inspection records and compliance data for AbleNet, Inc. in Roseville, Minnesota. 2 FDA inspections on record, 1 Form 483, last inspected July 08, 2024.
Company Profile
This profile covers AbleNet, Inc. based in Roseville, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected November 20, 2017. Last inspected July 8, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Lack of Written MDR Procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 8, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1243751 |
| November 20, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1031779 |
FDA documents
Form 483s (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
AbleNet, Inc.
FEI Number
3001576173
Address
2625 Patton Rd, Roseville, Minnesota 55113, United States
Country
United States
ID: ab4523e3-ec2f-4c11-bad3-e8f12ea8db53