FDA Inspection
Cochlear Americas Inc.Cochlear Americas Inc. – FDA Inspection, Feb 22, 2018
Record Details
This FDA Inspection record concerns Cochlear Americas Inc., with an inspection on February 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f52c5908-6cf3-472f-b7bb-98803aa99204
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042149
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(5)Sponsor records of adverse device effects & complaints
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Cochlear Americas Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2021 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 28, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1155204 - 2021-10-21
- FDA Inspection 1078710 - 2018-11-28
- FDA Inspection 855809 - 2013-10-22
- FDA Inspection 849948 - 2013-09-18
- FDA Inspection 582805 - 2009-05-12
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