FDA Inspection
Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Corp. – FDA Inspection, Feb 9, 2010
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corp., with an inspection on February 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 9, 2010
- Product Type
- Drugs
View Company Profile
ID · 46c998a4-3857-4aba-94a3-4e0c4903968a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.81(b)(2)(iii)Labeling information
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| 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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