Company
United StatesDaiichi Sankyo, Inc., Basking Ridge, NJ – FDA Inspections
Inspection records and compliance data for Daiichi Sankyo, Inc. in Basking Ridge, New Jersey. 11 FDA inspections on record, 2 Form 483s, last inspected May 04, 2026.
Company Profile
This profile covers Daiichi Sankyo, Inc. based in Basking Ridge, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 4
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 12, 2010. Last inspected May 4, 2026.
Most cited issue areas
- General responsibilities of sponsors3 inspections
- Failure to comply with REMS Elements to Assure Safe Use (ETASU) A1 inspection
- Failure to comply with REMS Implementation System1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 4, 2026 | Not classified | Human Drugs | 1318108 |
| August 1, 2025 | VAI | Human Drugs · Postmarketing Surveillance and Epidemiology: Human Drugs | 1277224 |
| November 30, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1192012 |
| July 15, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1176597 |
| April 8, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1168866 |
| March 30, 2021 | NAI | Human Drugs · Bioresearch Monitoring | 1141831 |
| January 8, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1076061 |
| May 19, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1014497 |
| September 9, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 889721 |
| January 4, 2011 | VAI | Human Drugs · Bioresearch Monitoring | 704457 |
| August 12, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 675886 |
FDA documents
Form 483s (1)
Other FDA documents (2)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Daiichi Sankyo, Inc.
FEI Number
3003089536
Address
211 Mount Airy Rd, Basking Ridge, New Jersey 07920, United States
Country
United States
ID: fd789c74-6b2b-43fb-800d-326eceeb1aea