FDA inspection

BioFire Diagnostics, LLC: FDA inspection ending Oct 23, 2017

FDA inspection 1045120 · No Action Indicated (NAI) · Salt Lake City, UT

Key facts

Inspection ID 1045120
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 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

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