FDA Inspection 849117 — Medikomp Gmbh
The FDA completed an inspection of Medikomp Gmbh on August 15, 2013 in Rastatt. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rastatt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |