FDA Inspection
RAUMEDIC - MUENCHBERGRAUMEDIC - MUENCHBERG – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns RAUMEDIC - MUENCHBERG, with an inspection on February 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 499ddc9e-b4a1-49bc-837c-d2efd3b6658a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196563
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of RAUMEDIC - MUENCHBERG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| January 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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