FDA inspection
BioFire Diagnostics, LLC: FDA inspection ending Oct 23, 2017
FDA inspection 1046822 · Voluntary Action Indicated (VAI) · Salt Lake City, UT
Key facts
| Inspection ID | 1046822 |
|---|---|
| Firm | BioFire Diagnostics, LLC |
| FEI number | 3002773840 |
| Address | 515 S Colorow Dr |
| City | Salt Lake City |
| State | UT |
| ZIP | 84108-1248 |
| Fiscal year | 2018 |
| Inspection end date | Oct 23, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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