FDA Inspection 858345 — Materialise USA LLC
The FDA completed an inspection of Materialise USA LLC on December 10, 2013 in Plymouth, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 10, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plymouth, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 4208 | 21 CFR 806.20(a) | Records not kept |