Company
GermanyDaiichi Sankyo Europe GmbH, Pfaffenhofen A.D.Ilm, Germany – FDA Inspections
Inspection records and compliance data for Daiichi Sankyo Europe GmbH in Pfaffenhofen A.D.Ilm. 6 FDA inspections on record, 1 Form 483, last inspected July 18, 2025.
Company Profile
This profile covers Daiichi Sankyo Europe GmbH based in Pfaffenhofen A.D.Ilm, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 29, 2010. Last inspected July 18, 2025.
Most cited issue areas
- Complete test data included in records1 inspection
- Investigations of discrepancies, failures1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1275919 |
| October 19, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1073797 |
| June 9, 2017 | Not classified | Human Drugs | 1019118 |
| May 15, 2014 | NAI | Human Drugs · Drug Quality Assurance | 882156 |
| September 20, 2012 | NAI | Human Drugs · Drug Quality Assurance | 802508 |
| January 29, 2010 | NAI | Human Drugs · Drug Quality Assurance | 649526 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Daiichi Sankyo Europe GmbH
FEI Number
3003282622
Address
Luitpoldstr. 1, Pfaffenhofen A.D.Ilm, Germany
Country
Germany
ID: 772636a4-cbb8-47ae-8aa1-fdc45ab325f6