FDA inspection

Baylor St Luke's Medical Center IRB & Research: FDA inspection ending Aug 23, 2007

FDA inspection 484973 · Voluntary Action Indicated (VAI) · Houston, TX

Key facts

Inspection ID 484973
Firm Baylor St Luke's Medical Center IRB & Research
FEI number 1641343
Address 6720 Bertner St, MC 3-288 (5th Floor, Room O-510)
City Houston
State TX
ZIP 77030-2604
Fiscal year 2007
Inspection end date Aug 23, 2007
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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