FDA Inspection
Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon Pharma Co., Ltd. – FDA Inspection, Apr 16, 2019
Record Details
This FDA Inspection record concerns Sumitomo Dainippon Pharma Co., Ltd., with an inspection on April 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7a4e397a-ac18-4bee-996b-e502e1b4dad2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088923
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Sumitomo Dainippon Pharma Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| February 17, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sumitomo Dainippon Pharma Co., Ltd.
- FDA Inspection 1276963 - 2025-07-11
- FDA Inspection 1003840 - 2017-02-17
- FDA Inspection 895955 - 2014-09-12
- FDA Inspection 797370 - 2012-02-24
- FDA Inspection 676813 - 2010-07-30
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