FDA Inspection
Fink Engineering Pty. Ltd.Fink Engineering Pty. Ltd. – FDA Inspection, May 24, 2012
Record Details
This FDA Inspection record concerns Fink Engineering Pty. Ltd., with an inspection on May 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fink Engineering Pty. Ltd.
- Inspection Date
- May 24, 2012
- Product Type
- Devices
View Company Profile
ID · fcd67302-5e5a-4cf5-bfc9-55ab8e56c258
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787968
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fink Engineering Pty. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| November 7, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 25, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fink Engineering Pty. Ltd.
- FDA Inspection 1259402 - 2025-01-28
- FDA Inspection 1112154 - 2019-11-07
- FDA Inspection 637168 - 2009-11-25
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