FDA Inspection
Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH – FDA Inspection, Jul 18, 2025
Record Details
This FDA Inspection record concerns Daiichi Sankyo Europe GmbH, with an inspection on July 18, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 02cc4ef0-7e2f-4314-a0e8-7193ad8f6f8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1275919
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Daiichi Sankyo Europe GmbH
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 9, 2017 | Not classified | Office of Inspections and Investigations | |
| May 15, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Daiichi Sankyo Europe GmbH
- FDA Inspection 1073797 - 2018-10-19
- FDA Inspection 1019118 - 2017-06-09
- FDA Inspection 882156 - 2014-05-15
- FDA Inspection 802508 - 2012-09-20
- FDA Inspection 649526 - 2010-01-29
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