FDA Inspection
Astellas Pharma US Inc.Astellas Pharma US Inc. – FDA Inspection, Nov 20, 2008
Record Details
This FDA Inspection record concerns Astellas Pharma US Inc., with an inspection on November 20, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Astellas Pharma US Inc.
- Inspection Date
- November 20, 2008
- Product Type
- Drugs
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ID · b5c6993b-14c8-48ce-a7a3-f16e2339d0ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547946
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Astellas Pharma US Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2026 | Not classified | Chicago District Office | |
| August 14, 2023 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 4, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 22, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 1, 2017 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for Astellas Pharma US Inc.
- FDA Inspection 1315968 - 2026-04-03
- FDA Inspection 1217117 - 2023-08-14
- FDA Inspection 1108572 - 2019-10-04
- FDA Inspection 1058496 - 2018-06-22
- FDA Inspection 1030399 - 2017-09-01
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