Company
JapanAstellas Pharma Inc., Takaoka, Japan – FDA Inspections
Inspection records and compliance data for Astellas Pharma Inc. in Takaoka. 6 FDA inspections on record, 2 Form 483s, last inspected June 06, 2025.
Company Profile
This profile covers Astellas Pharma Inc. based in Takaoka, Japan.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 7, 2008. Last inspected June 6, 2025.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Procedures for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 6, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1274944 |
| March 5, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1081668 |
| March 18, 2016 | NAI | Human Drugs · Drug Quality Assurance | 963371 |
| April 11, 2014 | VAI | Human Drugs · Drug Quality Assurance | 874760 |
| November 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 756552 |
| November 7, 2008 | VAI | Human Drugs · Drug Quality Assurance | 548559 |
FDA documents
Form 483s (2)
Other regulators (1)
- Health Canada · 1 inspection · last December 6, 2023
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Astellas Pharma Inc.
FEI Number
3002807001
Address
30, Toidesakaemachi, Takaoka, Japan
Country
Japan
ID: ad5c1a7d-23cf-412a-88ce-62ab257c3233