FDA inspection

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.: FDA inspection ending Feb 12, 2016

FDA inspection 958528 · Voluntary Action Indicated (VAI) · Tokushima

Key facts

Inspection ID 958528
Firm Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
FEI number 3002807834
Address 224-18, Kawauchi-Cho
City Tokushima
Country Japan
Fiscal year 2016
Inspection end date Feb 12, 2016
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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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