FDA inspection

OraSure Technologies, Inc.: FDA inspection ending Dec 13, 2018

FDA inspection 1077597 · No Action Indicated (NAI) · Bethlehem, PA

Key facts

Inspection ID 1077597
Firm OraSure Technologies, Inc.
FEI number 3004142665
Address 220 E 1st St
City Bethlehem
State PA
ZIP 18015
Country United States
Fiscal year 2019
Inspection end date Dec 13, 2018
Classification No Action Indicated (NAI)
Project area Radiation Control and Health Safety Act
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No 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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