FDA Inspection
RAUMEDIC - MUENCHBERGRAUMEDIC - MUENCHBERG – FDA Inspection, Jan 29, 2015
Record Details
This FDA Inspection record concerns RAUMEDIC - MUENCHBERG, with an inspection on January 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RAUMEDIC - MUENCHBERG
- Inspection Date
- January 29, 2015
- Product Type
- Devices
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ID · e1a74c0b-e1e3-4eeb-b8a2-52b327597ad0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917689
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of RAUMEDIC - MUENCHBERG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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