FDA inspection

Baxalta Manufacturing Sarl: FDA inspection ending Nov 12, 2018

FDA inspection 1073390 · Voluntary Action Indicated (VAI) · Neuchatel

Key facts

Inspection ID 1073390
Firm Baxalta Manufacturing Sarl
FEI number 3002689389
Address Route De Pierre-A-Bot 111
City Neuchatel
Country Switzerland
Fiscal year 2019
Inspection end date Nov 12, 2018
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
  • 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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