Company
United StatesActelion Pharmaceuticals US Inc. – FDA Inspections
Inspection records and compliance data for Actelion Pharmaceuticals US Inc. in Unknown. 1 FDA inspection on record, 1 Form 483, last inspected October 28, 2024.
Company Profile
This profile covers Actelion Pharmaceuticals US Inc. based in Unknown, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected October 28, 2024.
Most cited issue areas
- Failure to comply with REMS Elements to Assure Safe Use (ETASU) B1 inspection
- Failure to comply with REMS Implementation System1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2024 | VAI | Human Drugs · Postmarketing Surveillance and Epidemiology: Human Drugs | 1252745 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Actelion Pharmaceuticals US Inc.
FEI Number
3021902393
Address
Unknown, Unknown Unknown, United States
Country
United States
ID: dcd7e330-a940-41bf-bf05-d121684e4612