FDA Inspection
Astellas Pharma Inc.Astellas Pharma Inc. – FDA Inspection, Mar 5, 2019
Record Details
This FDA Inspection record concerns Astellas Pharma Inc., with an inspection on March 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a24c61dd-8240-493f-bad1-7c0abd0c4f4c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081668
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Astellas Pharma Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | VAI | Office of Inspections and Investigations | 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 1274944 - 2025-06-06
- 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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