FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on February 1, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 46a4e1d0-2f16-4b71-9938-52b747c13d19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082945
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Otsuka Pharmaceutical Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2025 | Not classified | Office of Inspections and Investigations | |
| 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 1279569 - 2025-07-11
- 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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