FDA Inspection
Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Corp. – FDA Inspection, Dec 21, 2010
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corp., with an inspection on December 21, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 21, 2010
- Product Type
- Drugs
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ID · 2b81d150-e371-43c3-8aad-2a7cc5e026dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704290
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(6)Inspection of packaging and labeling area
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| 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 811624 - 2012-12-19
- FDA Inspection 764997 - 2012-01-31
- FDA Inspection 680379 - 2010-09-16
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