FDA Inspection 1308002 — ARxIUM Inc.
The FDA completed an inspection of ARxIUM Inc. on March 12, 2026 in Winnipeg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winnipeg (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23263 | 21 CFR 820.35(a) | Records for complaints involving failure to meet specifications not maintained |