FDA Inspection
Audifon-USA, Inc.Audifon-USA, Inc. – FDA Inspection, Apr 1, 2010
Record Details
This FDA Inspection record concerns Audifon-USA, Inc., with an inspection on April 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Audifon-USA, Inc.
- Inspection Date
- April 1, 2010
- Product Type
- Devices
View Company Profile
ID · 9f8b2688-bbc5-4076-96ca-5db950e7fd74
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654100
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(a)General
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Audifon-USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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