FDA Inspection
Inion OyInion Oy – FDA Inspection, Nov 15, 2022
Record Details
This FDA Inspection record concerns Inion Oy, with an inspection on November 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inion Oy
- Inspection Date
- November 15, 2022
- Product Type
- Devices
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ID · 1f3d062f-6581-4d36-be11-5249890532fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190792
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Inion Oy
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2025 | Not classified | Office of Inspections and Investigations | |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inion Oy
- FDA Inspection 1276424 - 2025-06-03
- FDA Inspection 841653 - 2013-06-20
- FDA Inspection 710111 - 2011-02-10
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