FDA inspection

Cook Childrens Health Care System IRB: FDA inspection ending Feb 17, 2004

FDA inspection 314219 · Voluntary Action Indicated (VAI) · Fort Worth, TX

Key facts

Inspection ID 314219
Firm Cook Childrens Health Care System IRB
FEI number 1640975
Address 1500 W Rosedale St
City Fort Worth
State TX
ZIP 76104-7403
Fiscal year 2004
Inspection end date Feb 17, 2004
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: 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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