Company
United StatesAstellas Pharma US Inc., Northbrook, IL – FDA Inspections
Inspection records and compliance data for Astellas Pharma US Inc. in Northbrook, Illinois. 10 FDA inspections on record (1 OAI), last inspected April 03, 2026.
Company Profile
This profile covers Astellas Pharma US Inc. based in Northbrook, Illinois, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 3
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 20, 2008. Last inspected April 3, 2026.
Most cited issue areas
- Ensuring compliance with plan and protocol1 inspection
- Late submission of 15-day report1 inspection
- No investigation agreement statement of commitment1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 3, 2026 | Not classified | Human Drugs | 1315968 |
| August 14, 2023 | OAI | Human Drugs · Bioresearch Monitoring | 1217117 |
| October 4, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1108572 |
| June 22, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1058496 |
| September 1, 2017 | NAI | Biologics, Human Drugs · Bioresearch Monitoring | 1030399 |
| February 12, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 864055 |
| February 27, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 769358 |
| August 23, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 740776 |
| November 20, 2008 | VAI | Human Drugs · Bioresearch Monitoring | 547946 |
| November 20, 2008 | NAI | Human Drugs · Drug Quality Assurance | 547918 |
FDA documents
EIRs (1)
Other FDA documents (3)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Astellas Pharma US Inc.
FEI Number
1000036852
Address
2375 Waterview Dr, Northbrook, Illinois 60062, United States
Country
United States
ID: 3bb1b330-7226-4071-b93b-2854ea7577cb