FDA Inspection 894893 — Dreve Otoplastik Gmbh
The FDA completed an inspection of Dreve Otoplastik Gmbh on August 21, 2014 in Unna. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Unna (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 537 | 21 CFR 820.70(a) | Production processes |