FDA Inspection 1018320 — Dr. Gernot Schuhfried Ges.m.b.H.
The FDA completed an inspection of Dr. Gernot Schuhfried Ges.m.b.H. on May 18, 2017 in Modling. 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
- May 18, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Modling (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |