Company
United StatesJanssen Pharmaceuticals, dba Actelion Pharmaceutical, South San Francisco, CA – FDA Inspections
Inspection records and compliance data for Janssen Pharmaceuticals, dba Actelion Pharmaceutical in South San Francisco, California. 5 FDA inspections on record (1 OAI), last inspected February 28, 2019.
Company Profile
This profile covers Janssen Pharmaceuticals, dba Actelion Pharmaceutical based in South San Francisco, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 20, 2009. Last inspected February 28, 2019.
Most cited issue areas
- Failure to develop written procedures4 inspections
- Late submission of 15-day report2 inspections
- Failure by applicant to report ADE1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 28, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1091668 |
| September 21, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 988929 |
| February 12, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 873005 |
| July 21, 2011 | VAI | Human Drugs · Bioresearch Monitoring | 735438 |
| July 20, 2009 | OAI | Human Drugs · Bioresearch Monitoring | 599116 |
FDA documents
EIRs (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Janssen Pharmaceuticals, dba Actelion Pharmaceutical
FEI Number
3003498827
Address
5000 Shoreline Ct Ste 200, South San Francisco, California 94080, United States
Country
United States
ID: 8d00c775-7a8c-41d5-aa2d-f2154459469d