FDA Inspection
Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Corp. – FDA Inspection, Mar 31, 2009
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corp., with an inspection on March 31, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 31, 2009
- Product Type
- Drugs
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ID · 1803445d-1bb6-4ddb-8d92-cac99a33ef16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572781
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
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 |
| December 19, 2012 | VAI | 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 |
Other documents for Novartis Pharmaceuticals Corp.
- FDA Inspection 936188 - 2015-07-14
- FDA Inspection 866692 - 2014-02-11
- FDA Inspection 811624 - 2012-12-19
- FDA Inspection 764997 - 2012-01-31
- FDA Inspection 704290 - 2010-12-21
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