Company
AustraliaCyclomedica Australia Pty Ltd, Kingsgrove, Australia – FDA Inspections
Inspection records and compliance data for Cyclomedica Australia Pty Ltd in Kingsgrove, New South Wales. 3 FDA inspections on record, 2 Form 483s, last inspected September 25, 2024.
Company Profile
This profile covers Cyclomedica Australia Pty Ltd based in Kingsgrove, New South Wales, Australia.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected February 8, 2019. Last inspected September 25, 2024.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2024 | Not classified | Human Drugs | 1253733 |
| August 8, 2023 | VAI | Human Drugs | 1214903 |
| February 8, 2019 | Not classified | Medical Devices & Rad Health | 1123505 |
FDA documents
Form 483s (2)
Other FDA documents (1)
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Company Information
Name
Cyclomedica Australia Pty Ltd
FEI Number
3009638066
Address
Unit 4 1 The Crescent, Kingsgrove, New South Wales 2208, Australia
Country
Australia
ID: 1e5c064b-db2c-472e-b270-eaf65f3ae1c7