FDA Inspection
Cochlear Americas Inc.Cochlear Americas Inc. – FDA Inspection, Oct 21, 2021
Record Details
This FDA Inspection record concerns Cochlear Americas Inc., with an inspection on October 21, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cochlear Americas Inc.
- Inspection Date
- October 21, 2021
- Product Type
- Devices
View Company Profile
ID · 9db55583-bf90-4f15-ae7b-f18a8d612bd9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155204
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
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Other FDA inspections of Cochlear Americas Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 22, 2018 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| October 22, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 12, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Cochlear Americas Inc.
- FDA Inspection 1078710 - 2018-11-28
- FDA Inspection 1042149 - 2018-02-22
- FDA Inspection 855809 - 2013-10-22
- FDA Inspection 849948 - 2013-09-18
- FDA Inspection 582805 - 2009-05-12
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