FDA inspection

Shionogi Pharma Co., Ltd.: FDA inspection ending Jun 3, 2016

FDA inspection 974314 · Voluntary Action Indicated (VAI) · Amagasaki

Key facts

Inspection ID 974314
Firm Shionogi Pharma Co., Ltd.
FEI number 3006396183
Address 2 Chome 1-3, Kuiseterajima
City Amagasaki
Country Japan
Fiscal year 2016
Inspection end date Jun 3, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 1–9 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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