FDA inspection

Otsuka Pharmaceutical Co., Ltd.: FDA inspection ending Feb 1, 2019

FDA inspection 1082945 · Voluntary Action Indicated (VAI) · Kanzaki-Gun

Key facts

Inspection ID 1082945
Firm Otsuka Pharmaceutical Co., Ltd.
FEI number 3003808559
Address Otsukaseiyaku (Kabu) Sagakojo, Azahigashiyama 5006-5; Omagari; Yoshinogari-Cho; Omagari; Yoshinogari-Cho; Omagari; Yoshinogari-Cho
City Kanzaki-Gun
Country Japan
Fiscal year 2019
Inspection end date Feb 1, 2019
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

Browse all FDA inspections