FDA Inspection 839516 — Trokamed GmbH
The FDA completed an inspection of Trokamed GmbH on June 27, 2013 in Geisingen. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Geisingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3159 | 21 CFR 820.184 | DHR content |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |