FDA Inspection
BioFire Diagnostics, LLCBioFire Diagnostics, LLC – FDA Inspection, Oct 23, 2017
Record Details
This FDA Inspection record concerns BioFire Diagnostics, LLC, with an inspection on October 23, 2017, issued by the Denver District Office, covering medical devices & rad health.
- Company
- BioFire Diagnostics, LLC
- Inspection Date
- October 23, 2017
- Product Type
- Medical Devices & Rad Health
- Office
- Denver District Office
View Company Profile
ID · 150dcba7-6114-45f3-a9ed-a1050e7e6f9b
Inspection Facts
- Inspection number
- 1046822
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of BioFire Diagnostics, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 | |
| March 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioFire Diagnostics, LLC
- FDA Inspection 1235522 - 2024-04-05
- FDA Inspection 1148989 - 2021-08-05
- FDA Inspection 1082140 - 2018-05-15
- FDA Inspection 1045120 - 2017-10-23
- FDA Inspection 964419 - 2016-03-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.