FDA Inspection
Janssen Pharmaceuticals, dba Actelion PharmaceuticalJanssen Pharmaceuticals, dba Actelion Pharmaceutical – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, dba Actelion Pharmaceutical, with an inspection on February 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 12, 2014
- Product Type
- Drugs
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ID · b132a489-5352-42c8-b852-0b7ab1f244fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873005
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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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 |
| July 21, 2011 | 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 735438 - 2011-07-21
- FDA Inspection 599116 - 2009-07-20
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