FDA Inspection 1254938 — DRG Instruments GmbH
The FDA completed an inspection of DRG Instruments GmbH on Nov 7, 2024 in Marburg. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 7, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |