FDA inspection

Gentium SRL: FDA inspection ending Dec 17, 2021

FDA inspection 1222279 · Voluntary Action Indicated (VAI) · Villa Guardia

Key facts

Inspection ID 1222279
Firm Gentium SRL
FEI number 3003744181
Address Piazza Venti Settembre 2
City Villa Guardia
Country Italy
Fiscal year 2022
Inspection end date Dec 17, 2021
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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