FDA Inspection
Audifon GmbhAudifon Gmbh – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns Audifon Gmbh, with an inspection on May 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 6facc4a2-ac66-4f8d-8c73-43c79f536569
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013135
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 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(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Audifon Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| December 18, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Audifon Gmbh
- FDA Inspection 1260616 - 2025-01-16
- FDA Inspection 1114379 - 2019-12-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.