FDA inspection

Otsuka Chemical Co., Ltd.: FDA inspection ending Dec 1, 2017

FDA inspection 1037940 · Voluntary Action Indicated (VAI) · Tokushima

Key facts

Inspection ID 1037940
Firm Otsuka Chemical Co., Ltd.
FEI number 3004392559
Address Otsukakagaku ( Kabu ) Tokushimakojo, Kagasuno 463; Kawauchi-Machi
City Tokushima
Country Japan
Fiscal year 2018
Inspection end date Dec 1, 2017
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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