FDA Inspection
UnitedHealthcare HearingUnitedHealthcare Hearing – FDA Inspection, Nov 30, 2018
Record Details
This FDA Inspection record concerns UnitedHealthcare Hearing, with an inspection on November 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ab487ac4-61d7-4776-932c-b1719f66f5dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073393
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of UnitedHealthcare Hearing
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for UnitedHealthcare Hearing
- FDA Inspection 996276 - 2016-12-07
- FDA Inspection 843984 - 2013-08-12
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