Company
AustraliaFink Engineering Pty. Ltd., Warana, Australia – FDA Inspections
Inspection records and compliance data for Fink Engineering Pty. Ltd. in Warana. 4 FDA inspections on record, 1 Form 483, last inspected January 28, 2025.
Company Profile
This profile covers Fink Engineering Pty. Ltd. based in Warana, Australia.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected November 25, 2009. Last inspected January 28, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Justification for not reporting1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1259402 |
| November 7, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1112154 |
| May 24, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 787968 |
| November 25, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 637168 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fink Engineering Pty. Ltd.
FEI Number
3006097795
Address
14 Premier Circuit, Warana, Australia
Country
Australia
ID: e14c0a51-e992-4d58-ba5c-7f2ed44a695d