FDA Inspection
GN Hearing Care CorporationGN Hearing Care Corporation – FDA Inspection, Jan 10, 2018
Record Details
This FDA Inspection record concerns GN Hearing Care Corporation, with an inspection on January 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Marissa S. Steinhagen (Issuing Officer)
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ID · 5518cab9-099d-4c60-8677-46ad8fe0ceda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037254
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of GN Hearing Care Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GN Hearing Care Corporation
- FDA Inspection 824925 - 2013-04-01
- FDA Inspection 733296 - 2011-06-28
- FDA Inspection 662331 - 2010-05-17
- FDA Inspection 661850 - 2010-04-28
- FDA Inspection 579054 - 2009-04-22
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