FDA Inspection
Inion OyInion Oy – FDA Inspection, Feb 10, 2011
Record Details
This FDA Inspection record concerns Inion Oy, with an inspection on February 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inion Oy
- Inspection Date
- February 10, 2011
- Product Type
- Devices
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ID · 9fc686d7-21db-49dc-9779-457244f68aee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710111
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 | |
| November 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Inion Oy
- FDA Inspection 1276424 - 2025-06-03
- FDA Inspection 1190792 - 2022-11-15
- FDA Inspection 841653 - 2013-06-20
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