FDA inspection

Industria Farmaceutica Galenica Senese Srl: FDA inspection ending Nov 16, 2018

FDA inspection 1072117 · Voluntary Action Indicated (VAI) · Monteroni D'Arbia

Key facts

Inspection ID 1072117
Firm Industria Farmaceutica Galenica Senese Srl
FEI number 3006994492
Address Via Cassia Nord 351
City Monteroni D'Arbia
Country Italy
Fiscal year 2019
Inspection end date Nov 16, 2018
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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