FDA Inspection
Janssen Pharmaceuticals, dba Actelion PharmaceuticalJanssen Pharmaceuticals, dba Actelion Pharmaceutical – FDA Inspection, Jul 20, 2009
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, dba Actelion Pharmaceutical, with an inspection on July 20, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 20, 2009
- Product Type
- Drugs
View Company Profile
ID · 9e7f7edd-3f62-4ce4-8177-85960a87eec3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 599116
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Janssen Pharmaceuticals, dba Actelion Pharmaceutical
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 21, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 12, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 21, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Janssen Pharmaceuticals, dba Actelion Pharmaceutical
- FDA Inspection 1091668 - 2019-02-28
- FDA Inspection 988929 - 2016-09-21
- FDA Inspection 873005 - 2014-02-12
- FDA Inspection 735438 - 2011-07-21
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