FDA Inspection
Audina Hearing InstrumentAudina Hearing Instrument – FDA Inspection, May 16, 2017
Record Details
This FDA Inspection record concerns Audina Hearing Instrument, with an inspection on May 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
View Company Profile
ID · dc7f2c3f-88a4-43e4-8e4f-e1fd45a4f2c0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1013192
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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.