Company
CanadaARxIUM Inc., Winnipeg, Canada – FDA Inspections
Inspection records and compliance data for ARxIUM Inc. in Winnipeg. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 12, 2026.
Company Profile
This profile covers ARxIUM Inc. based in Winnipeg, Canada.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 22, 2011. Last inspected March 12, 2026.
Most cited issue areas
- Records for complaints involving failure to meet specifications not maintained1 inspection
- Records of risk management activities in product realization not maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 12, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1308002 |
| March 27, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 825720 |
| September 22, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 750674 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ARxIUM Inc.
FEI Number
3006227536
Address
96 Nature Park Way, Winnipeg, Canada
Country
Canada
ID: 6becad1e-3020-4f5b-a8cb-6d0f43614b89