FDA inspection

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.: FDA inspection ending Mar 22, 2024

FDA inspection 1230640 · Voluntary Action Indicated (VAI) · Tokushima

Key facts

Inspection ID 1230640
Firm Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
FEI number 3002807834
Address 224-18, Kawauchi-Cho
City Tokushima
Country Japan
Fiscal year 2024
Inspection end date Mar 22, 2024
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
  • 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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