FDA inspection
BioFire Diagnostics, LLC: FDA inspection ending May 15, 2018
FDA inspection 1082140 · No Action Indicated (NAI) · Salt Lake City, UT
Key facts
| Inspection ID | 1082140 |
|---|---|
| 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 | May 15, 2018 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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