Company
United StatesBioFire Diagnostics, LLC, Salt Lake City, UT – FDA Inspections
Inspection records and compliance data for BioFire Diagnostics, LLC in Salt Lake City, Utah. 8 FDA inspections on record, 1 Form 483, last inspected April 05, 2024.
Company Profile
This profile covers BioFire Diagnostics, LLC based in Salt Lake City, Utah, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Unclassified
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected August 5, 2010. Last inspected April 5, 2024.
Most cited issue areas
- Evaluation, timeliness, identification1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 5, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1235522 |
| August 5, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1148989 |
| May 15, 2018 | Not classified | Medical Devices & Rad Health | 1082140 |
| October 23, 2017 | Not classified | Medical Devices & Rad Health | 1046822 |
| October 23, 2017 | Not classified | Medical Devices & Rad Health | 1045120 |
| March 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 964419 |
| October 18, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 803712 |
| August 5, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 678758 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BioFire Diagnostics, LLC
FEI Number
3002773840
Address
515 S Colorow Dr, Salt Lake City, Utah 84108, United States
Country
United States
ID: 42f061ce-087c-4ae8-ab03-752cae683764