FDA Inspection
Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Corp. – FDA Inspection, Dec 19, 2012
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corp., with an inspection on December 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 19, 2012
- Product Type
- Drugs
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ID · 229bd035-f48f-4dc4-b65a-35c52cc06b95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Novartis Pharmaceuticals Corp.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novartis Pharmaceuticals Corp.
- FDA Inspection 936188 - 2015-07-14
- FDA Inspection 866692 - 2014-02-11
- FDA Inspection 764997 - 2012-01-31
- FDA Inspection 704290 - 2010-12-21
- FDA Inspection 680379 - 2010-09-16
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