FDA Inspection
ARxIUM Inc.ARxIUM Inc. – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns ARxIUM Inc., with an inspection on March 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · aed734dc-bbf1-47e4-a76b-2bc453896c18
Inspection Facts
- Inspection number
- 1308002
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- 21 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
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Other FDA inspections of ARxIUM Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 22, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ARxIUM Inc.
- FDA Inspection 825720 - 2013-03-27
- FDA Inspection 750674 - 2011-09-22
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