FDA Inspection
RSPRINT Powered by Materialise N.V.RSPRINT Powered by Materialise N.V. – FDA Inspection, Apr 23, 2013
Record Details
This FDA Inspection record concerns RSPRINT Powered by Materialise N.V., with an inspection on April 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 23, 2013
- Product Type
- Devices
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ID · 8fdd3d1e-2b8b-4c56-8ab2-e29af666a6e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835113
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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