FDA Inspection
Astellas Pharma Inc.Astellas Pharma Inc. – FDA Inspection, Jun 6, 2025
Record Details
This FDA Inspection record concerns Astellas Pharma Inc., with an inspection on June 6, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · dd27836e-06a5-4845-980e-a356aeaafacc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274944
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Astellas Pharma Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Astellas Pharma Inc.
- FDA Inspection 1081668 - 2019-03-05
- FDA Inspection 963371 - 2016-03-18
- FDA Inspection 874760 - 2014-04-11
- FDA Inspection 756552 - 2011-11-21
- FDA Inspection 548559 - 2008-11-07
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