FDA inspection

Novartis d.o.o.: FDA inspection ending Jan 25, 2023

FDA inspection 1230625 · Voluntary Action Indicated (VAI) · Ljubljana

Key facts

Inspection ID 1230625
Firm Novartis d.o.o.
FEI number 3013358387
Address Verovskova Ulica 57
City Ljubljana
Country Slovenia
Fiscal year 2023
Inspection end date Jan 25, 2023
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
  • 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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