Company
JapanAstellas Pharma Inc., Toyama, Japan – FDA Inspections
Inspection records and compliance data for Astellas Pharma Inc. in Toyama. 7 FDA inspections on record, 2 Form 483s, last inspected April 18, 2024.
Company Profile
This profile covers Astellas Pharma Inc. based in Toyama, Japan.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected October 31, 2008. Last inspected April 18, 2024.
Most cited issue areas
- Documentation1 inspection
- Prepared for each batch, include complete information1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2024 | NAI | Human Drugs · Drug Quality Assurance | 1240584 |
| May 31, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1095974 |
| March 2, 2018 | VAI | Human Drugs · New Drug Evaluation | 1042616 |
| November 11, 2016 | VAI | Human Drugs · Drug Quality Assurance | 995338 |
| June 25, 2014 | NAI | Human Drugs · Drug Quality Assurance | 886636 |
| February 10, 2012 | NAI | Human Drugs · Drug Quality Assurance | 770005 |
| October 31, 2008 | VAI | Human Drugs · Drug Quality Assurance | 548515 |
FDA documents
Form 483s (1)
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Company Information
Name
Astellas Pharma Inc.
FEI Number
3002807003
Address
2-178, Kojin-Machi, Toyama, Japan
Country
Japan
ID: 9a5bc049-426d-4313-b8b8-1ce28d48fa42