FDA Inspection
Actelion Pharmaceuticals Ltd.Actelion Pharmaceuticals Ltd. – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Actelion Pharmaceuticals Ltd., with an inspection on September 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2011
- Product Type
- Drugs
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ID · 5c4c150a-8195-4b3d-b294-eee53a49ca69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 748072
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Actelion Pharmaceuticals Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 22, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 13, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Actelion Pharmaceuticals Ltd.
- FDA Inspection 937014 - 2015-07-16
- FDA Inspection 939398 - 2015-05-22
- FDA Inspection 853246 - 2013-09-13
- FDA Inspection 828132 - 2013-04-19
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