FDA Inspection
Audifon-USA, Inc.Audifon-USA, Inc. – FDA Inspection, Nov 27, 2018
Record Details
This FDA Inspection record concerns Audifon-USA, Inc., with an inspection on November 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ee0749f2-572d-484c-8683-89566b3f00c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Audifon-USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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