FDA Inspection 734689 — AGFA-GEVAERT HEALTHCARE GMBH
The FDA completed an inspection of AGFA-GEVAERT HEALTHCARE GMBH on Jul 8, 2011 in Munich. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 8, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Munich (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |