FDA inspection

Baxalta Inc. Baxter AG: FDA inspection ending May 7, 2015

FDA inspection 948059 · Voluntary Action Indicated (VAI) · Vienna

Key facts

Inspection ID 948059
Firm Baxalta Inc. Baxter AG
FEI number 3002807133
Address Industriestrase 131
City Vienna
Fiscal year 2015
Inspection end date May 7, 2015
Classification Voluntary Action Indicated (VAI)
Project area Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products
Product type Biologics

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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