FDA Inspection
Bernd Richter GmbHBernd Richter GmbH – FDA Inspection, Feb 16, 2023
Record Details
This FDA Inspection record concerns Bernd Richter GmbH, with an inspection on February 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 09e32135-f49b-486b-b70b-a82427fb252c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198120
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of Bernd Richter GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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