FDA Inspection 835113 — RSPRINT Powered By Materialise N.V.
The FDA completed an inspection of RSPRINT Powered By Materialise N.V. on Apr 23, 2013 in Paal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Paal (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3837 | 21 CFR 820.25(b) | Training records |