FDA inspection

Baxalta Belgium Manufacturing SA: FDA inspection ending May 31, 2019

FDA inspection 1093550 · Voluntary Action Indicated (VAI) · Lessines

Key facts

Inspection ID 1093550
Firm Baxalta Belgium Manufacturing SA
FEI number 3002806503
Address Boulevard Rene Branquart 80
City Lessines
Country Belgium
Fiscal year 2019
Inspection end date May 31, 2019
Classification Voluntary Action Indicated (VAI)
Project area 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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