FDA inspection

R2 Diagnostics, Inc.: FDA inspection ending Apr 30, 2002

FDA inspection 214864 · Voluntary Action Indicated (VAI) · South Bend, IN

Key facts

Inspection ID 214864
Firm R2 Diagnostics, Inc.
FEI number 3000210416
Address 1801 Commerce Dr
City South Bend
State IN
ZIP 46628-1562
Fiscal year 2002
Inspection end date Apr 30, 2002
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None 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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