FDA Inspection
Audifon GmbhAudifon Gmbh – FDA Inspection, Jan 16, 2025
Record Details
This FDA Inspection record concerns Audifon Gmbh, with an inspection on January 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 1b27d5b8-fd89-4a66-9d93-b33bac1ad25b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260616
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Audifon Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Audifon Gmbh
- FDA Inspection 1114379 - 2019-12-18
- FDA Inspection 1013135 - 2017-05-11
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