678758

BioFire Diagnostics, LLC — FEI 3002773840

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

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472121 CFR 820.70(g)(2)Periodic equipment inspections
405921 CFR 820.22Quality Audits - defined intervals