FDA Inspection
Astellas Pharma Inc.Astellas Pharma Inc. – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns Astellas Pharma Inc., with an inspection on March 2, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 64d4d1f9-e83d-4990-a597-13579281149e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042616
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Astellas Pharma Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Astellas Pharma Inc.
- FDA Inspection 1240584 - 2024-04-18
- FDA Inspection 1095974 - 2019-05-31
- FDA Inspection 995338 - 2016-11-11
- FDA Inspection 886636 - 2014-06-25
- FDA Inspection 770005 - 2012-02-10
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