FDA Inspection
Fluke Biomedical LLCFluke Biomedical LLC – FDA Inspection, Jan 18, 2024
Record Details
This FDA Inspection record concerns Fluke Biomedical LLC, with an inspection on January 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bbabb0ea-947a-404d-a409-bbb437510f68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1227243
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fluke Biomedical LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fluke Biomedical LLC
- FDA Inspection 1191060 - 2022-11-21
- FDA Inspection 1114053 - 2019-12-18
- FDA Inspection 995390 - 2016-12-14
- FDA Inspection 906946 - 2014-12-12
- FDA Inspection 806940 - 2012-11-20
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