Company
DenmarkXellia Pharmaceuticals ApS, Copenhagen S, Denmark – FDA Inspections
Inspection records and compliance data for Xellia Pharmaceuticals ApS in Copenhagen S. 7 FDA inspections on record, 1 Form 483, last inspected October 28, 2021.
Company Profile
This profile covers Xellia Pharmaceuticals ApS based in Copenhagen S, Denmark.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 7
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected February 11, 2010. Last inspected October 28, 2021.
Most cited issue areas
- Investigations of discrepancies, failures1 inspection
- Procedures for sterile drug products1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1244910 |
| October 25, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1123814 |
| May 8, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1051572 |
| March 15, 2016 | VAI | Human Drugs · Drug Quality Assurance | 975111 |
| May 6, 2014 | VAI | Human Drugs · Drug Quality Assurance | 880296 |
| October 16, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 806442 |
| February 11, 2010 | VAI | Human Drugs · Drug Quality Assurance | 651869 |
FDA documents
Other FDA documents (1)
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Company Information
Name
Xellia Pharmaceuticals ApS
FEI Number
3002806860
Address
Dalslandsgade 11, Copenhagen S, Denmark
Country
Denmark
ID: 5d9704ca-114e-4a65-abca-966a5c4e2a57