FDA Inspection
RAUMEDIC Estonia ASRAUMEDIC Estonia AS – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns RAUMEDIC Estonia AS, with an inspection on January 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 39336474-027c-4643-8367-225d8345b7c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002026
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of RAUMEDIC Estonia AS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RAUMEDIC Estonia AS
- FDA Inspection 819197 - 2013-01-29
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