Company
SwitzerlandActelion Pharmaceuticals Ltd., Allschwil, Switzerland – FDA Inspections
Inspection records and compliance data for Actelion Pharmaceuticals Ltd. in Allschwil. 5 FDA inspections on record, last inspected July 16, 2015.
Company Profile
This profile covers Actelion Pharmaceuticals Ltd. based in Allschwil, Switzerland.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 29, 2011. Last inspected July 16, 2015.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 937014 |
| May 22, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 939398 |
| September 13, 2013 | NAI | Human Drugs · Drug Quality Assurance | 853246 |
| April 19, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 828132 |
| September 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 748072 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
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Company Information
Name
Actelion Pharmaceuticals Ltd.
FEI Number
3002995923
Address
Gewerbestrasse 16, Allschwil, Switzerland
Country
Switzerland
ID: 6a69a862-a86e-4585-a629-480925833294