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FDA Inspection
•Otsuka Pharmaceutical Co. Ltd.•September 18, 2014

Otsuka Pharmaceutical Co. Ltd. – FDA Inspection, Sep 18, 2014

Record Details

This FDA Inspection record concerns Otsuka Pharmaceutical Co. Ltd., with an inspection on September 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Otsuka Pharmaceutical Co. Ltd.
Inspection Date
September 18, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 723b8f4a-3749-4560-a4cf-2cdcfe55014e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
899637
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of Otsuka Pharmaceutical Co. Ltd.

5
DateClassificationOfficeProject area
May 16, 2025NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 10, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 8, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 15, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 2, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Otsuka Pharmaceutical Co. Ltd.
  • FDA Inspection 1274284 - 2025-05-16
  • FDA Inspection 1112200 - 2019-10-10
  • FDA Inspection 1037241 - 2017-12-08
  • FDA Inspection 969641 - 2016-04-15
  • FDA Inspection 796785 - 2012-08-02

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