FDA Inspection
Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon Pharma Co., Ltd. – FDA Inspection, Jul 11, 2025
Record Details
This FDA Inspection record concerns Sumitomo Dainippon Pharma 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 · 959cb516-78a7-4b4f-96f4-d510481d7ed0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276963
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(c)Record review prior to release
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Other FDA inspections of Sumitomo Dainippon Pharma Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2019 | VAI | Center for Drug Evaluation and Research | 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 1088923 - 2019-04-16
- 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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