FDA Inspection
Cochlear LimitedCochlear Limited – FDA Inspection, Apr 11, 2013
Record Details
This FDA Inspection record concerns Cochlear Limited, with an inspection on April 11, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cochlear Limited
- Inspection Date
- April 11, 2013
- Product Type
- Devices
View Company Profile
ID · a403f875-1c40-470f-a74f-64d79dfa3be4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829416
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cochlear Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | Not classified | Office of Inspections and Investigations | |
| May 10, 2017 | Not classified | Office of Inspections and Investigations | |
| May 14, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 30, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cochlear Limited
- FDA Inspection 1095391 - 2019-06-06
- FDA Inspection 1021955 - 2017-05-10
- FDA Inspection 929859 - 2015-05-14
- FDA Inspection 608317 - 2009-07-30
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