FDA Inspection
BioFire Diagnostics, LLCBioFire Diagnostics, LLC – FDA Inspection, Apr 5, 2024
Record Details
This FDA Inspection record concerns BioFire Diagnostics, LLC, with an inspection on April 5, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 931b5488-77d8-46c5-a296-354d10ab443c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235522
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.198(d)Evaluation, timeliness, identification
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioFire Diagnostics, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 15, 2018 | Not classified | Denver District Office | |
| October 23, 2017 | Not classified | Denver District Office | |
| October 23, 2017 | Not classified | Denver District Office | |
| March 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioFire Diagnostics, LLC
- FDA Inspection 1148989 - 2021-08-05
- FDA Inspection 1082140 - 2018-05-15
- FDA Inspection 1046822 - 2017-10-23
- FDA Inspection 1045120 - 2017-10-23
- FDA Inspection 964419 - 2016-03-18
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