FDA Inspection
LINA Medical ApsLINA Medical Aps – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns LINA Medical Aps, with an inspection on March 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LINA Medical Aps
- Inspection Date
- March 22, 2011
- Product Type
- Devices
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ID · f6b6fdac-4cbc-4a4e-9a3a-00424ab1022f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719043
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
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Other FDA inspections of LINA Medical Aps
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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