FDA inspection

IU Health Bloomington Hospital IRB: FDA inspection ending May 8, 2008

FDA inspection 518360 · Voluntary Action Indicated (VAI) · Bloomington, IN

Key facts

Inspection ID 518360
Firm IU Health Bloomington Hospital IRB
FEI number 1832115
Address 601 W 2nd St
City Bloomington
State IN
ZIP 47403-2317
Fiscal year 2008
Inspection end date May 8, 2008
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: Med Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 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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