Company
CanadaRehabtronics Inc., Edmonton, Canada – FDA Inspections
Inspection records and compliance data for Rehabtronics Inc. in Edmonton. 4 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected July 13, 2023.
Company Profile
This profile covers Rehabtronics Inc. based in Edmonton, Canada.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected August 8, 2013. Last inspected July 13, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- DHR content2 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 13, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1210264 |
| September 28, 2018 | Not classified | Medical Devices & Rad Health | 1121814 |
| February 26, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 916001 |
| August 8, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 846373 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rehabtronics Inc.
FEI Number
3007999109
Address
4352-10230 Jasper Ave Nw, Edmonton, Canada
Country
Canada
ID: a163f46d-fb09-4071-be86-1be209f856ed