FDA inspection

Novartis Manufacturing NV: FDA inspection ending Nov 9, 2018

FDA inspection 1126883 · Voluntary Action Indicated (VAI) · Puurs-Sint-Amands

Key facts

Inspection ID 1126883
Firm Novartis Manufacturing NV
FEI number 3002037047
Address Rijksweg 14
City Puurs-Sint-Amands
Country Belgium
Fiscal year 2019
Inspection end date Nov 9, 2018
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
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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