FDA Inspection
Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Corp. – FDA Inspection, Jan 31, 2012
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corp., with an inspection on January 31, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 31, 2012
- Product Type
- Drugs
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ID · a6ff6688-fb83-4e60-81c0-b8321b957f80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 764997
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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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 |
| 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 811624 - 2012-12-19
- FDA Inspection 704290 - 2010-12-21
- FDA Inspection 680379 - 2010-09-16
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