FDA Inspection
Janssen Pharmaceuticals, dba Actelion PharmaceuticalJanssen Pharmaceuticals, dba Actelion Pharmaceutical – FDA Inspection, Jul 21, 2011
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, dba Actelion Pharmaceutical, with an inspection on July 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 21, 2011
- Product Type
- Drugs
View Company Profile
ID · 5ce130c7-ded5-48ca-bb07-293fd0b92f28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735438
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 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 20, 2009 | OAI | 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 599116 - 2009-07-20
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