FDA Inspection 1198120 — Bernd Richter GmbH
The FDA completed an inspection of Bernd Richter GmbH on Feb 16, 2023 in Wipperfurth. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 16, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wipperfurth (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |