Company
AustraliaEllex Medical Pty Ltd., Mawson Lakes, Australia – FDA Inspections
Inspection records and compliance data for Ellex Medical Pty Ltd. in Mawson Lakes. 1 FDA inspection on record, 1 Form 483, last inspected May 11, 2018.
Company Profile
This profile covers Ellex Medical Pty Ltd. based in Mawson Lakes, Australia.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 11, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Review and evaluation for investigation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 11, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1052407 |
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
Ellex Medical Pty Ltd.
FEI Number
3002806902
Address
3-4 Second Ave, Mawson Lakes, Australia
Country
Australia
ID: 455dc9b1-58eb-4694-a2b1-3d3d4b149577