FDA inspection

Novartis d.o.o.: FDA inspection ending Sep 11, 2020

FDA inspection 1155320 · Voluntary Action Indicated (VAI) · Menges

Key facts

Inspection ID 1155320
Firm Novartis d.o.o.
FEI number 3002807470
Address Kolodvorska cesta 27
City Menges
Country Slovenia
Fiscal year 2020
Inspection end date Sep 11, 2020
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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