FDA inspection

Janssen Biotech, Inc.: FDA inspection ending Aug 9, 2013

FDA inspection 843595 · Voluntary Action Indicated (VAI) · Malvern, PA

Key facts

Inspection ID 843595
Firm Janssen Biotech, Inc.
FEI number 3001610451
Address 200 Great Valley Pkwy
City Malvern
State PA
ZIP 19355-1307
Fiscal year 2013
Inspection end date Aug 9, 2013
Classification Voluntary Action Indicated (VAI)
Project area Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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