FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Jul 11, 2025
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on July 11, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 54c8099f-53c3-46b6-9fae-fac05b0ea2eb
Inspection Facts
- Inspection number
- 1279569
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
Other FDA inspections of Otsuka Pharmaceutical Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 25, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 14, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Otsuka Pharmaceutical Co., Ltd.
- FDA Inspection 1082945 - 2019-02-01
- FDA Inspection 969045 - 2016-04-08
- FDA Inspection 908834 - 2014-12-05
- FDA Inspection 795311 - 2012-07-25
- FDA Inspection 749028 - 2011-10-14
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