FDA inspection

Duke University Health System IRB: FDA inspection ending Sep 1, 2016

FDA inspection 987166 · No Action Indicated (NAI) · Durham, NC

Key facts

Inspection ID 987166
Firm Duke University Health System IRB
FEI number 1045114
Address 2424 Erwin Rd Ste 405
City Durham
State NC
ZIP 27705
Country United States
Fiscal year 2016
Inspection end date Sep 1, 2016
Classification No Action Indicated (NAI)
Project area Bioresearch Monitoring
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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