Company
AustraliaCochlear Limited, Lane Cove West, Australia – FDA Inspections
Inspection records and compliance data for Cochlear Limited in Lane Cove West. 5 FDA inspections on record, 1 Form 483, last inspected June 06, 2019.
Company Profile
This profile covers Cochlear Limited based in Lane Cove West, Australia.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected July 30, 2009. Last inspected June 6, 2019.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 6, 2019 | Not classified | Medical Devices & Rad Health | 1095391 |
| May 10, 2017 | Not classified | Medical Devices & Rad Health | 1021955 |
| May 14, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 929859 |
| April 11, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 829416 |
| July 30, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 608317 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cochlear Limited
FEI Number
3002806740
Address
14 Mars Rd, Lane Cove West, Australia
Country
Australia
ID: 521c9202-101c-4021-be63-c5a7bd90be15