FDA Inspection
Fink Engineering Pty. Ltd.Fink Engineering Pty. Ltd. – FDA Inspection, Jan 28, 2025
Record Details
This FDA Inspection record concerns Fink Engineering Pty. Ltd., with an inspection on January 28, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Fink Engineering Pty. Ltd.
- Inspection Date
- January 28, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · b6e14ea7-1de9-485d-a809-5c3dab998c0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259402
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.186QSR
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Other FDA inspections of Fink Engineering Pty. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 25, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fink Engineering Pty. Ltd.
- FDA Inspection 1112154 - 2019-11-07
- FDA Inspection 787968 - 2012-05-24
- FDA Inspection 637168 - 2009-11-25
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