FDA Inspection 678758 — BioFire Diagnostics, LLC
The FDA completed an inspection of BioFire Diagnostics, LLC on August 5, 2010 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |