FDA Inspection
Unitron Hearing IncUnitron Hearing Inc – FDA Inspection, Jan 12, 2016
Record Details
This FDA Inspection record concerns Unitron Hearing Inc, with an inspection on January 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unitron Hearing Inc
- Inspection Date
- January 12, 2016
- Product Type
- Devices
View Company Profile
ID · ff0d9001-3b96-41f2-8880-1146290ec894
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 977966
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Unitron Hearing Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Unitron Hearing Inc
- FDA Inspection 1012389 - 2017-04-04
- FDA Inspection 632332 - 2009-12-03
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