FDA Inspection 999374 — DRG Instruments GmbH
The FDA completed an inspection of DRG Instruments GmbH on Oct 28, 2016 in Marburg. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 28, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |