FDA Inspection
LINA Medical ApsLINA Medical Aps – FDA Inspection, Nov 1, 2017
Record Details
This FDA Inspection record concerns LINA Medical Aps, with an inspection on November 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca68ae14-0165-499d-a769-437387a583cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031380
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LINA Medical Aps
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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