FDA Inspection
Janssen Pharmaceuticals, dba Actelion PharmaceuticalJanssen Pharmaceuticals, dba Actelion Pharmaceutical – FDA Inspection, Sep 21, 2016
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, dba Actelion Pharmaceutical, with an inspection on September 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 21, 2016
- Product Type
- Drugs
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ID · a1a51288-f60d-4821-866f-1336cd61c325
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988929
- 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 |
| February 12, 2014 | 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 873005 - 2014-02-12
- FDA Inspection 735438 - 2011-07-21
- FDA Inspection 599116 - 2009-07-20
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