FDA Inspection
Icare Finland OyIcare Finland Oy – FDA Inspection, Sep 27, 2012
Record Details
This FDA Inspection record concerns Icare Finland Oy, with an inspection on September 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Icare Finland Oy
- Inspection Date
- September 27, 2012
- Product Type
- Devices
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ID · 61e8a87a-fb41-46cc-a8bb-fec1c19965d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803107
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Icare Finland Oy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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