FDA inspection
BioFire Diagnostics, LLC: FDA inspection ending Apr 5, 2024
FDA inspection 1235522 · Voluntary Action Indicated (VAI) · Salt Lake City, UT
Key facts
| Inspection ID | 1235522 |
|---|---|
| Firm | BioFire Diagnostics, LLC |
| FEI number | 3002773840 |
| Address | 515 S Colorow Dr |
| City | Salt Lake City |
| State | UT |
| ZIP | 84108 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Apr 5, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data