FDA Inspection
Sun Pharmaceutical Industries, LTD.Sun Pharmaceutical Industries, LTD. – FDA Inspection, May 12, 2009
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries, LTD., with an inspection on May 12, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 12, 2009
- Product Type
- Drugs
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ID · f9e7038f-bfc6-46b7-b25c-295ed66cc041
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 572444
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
26- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.192Extent of discrepancy, failure investigations
Showing 10 of 26 citations.
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Other FDA inspections of Sun Pharmaceutical Industries, LTD.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sun Pharmaceutical Industries, LTD.
- FDA Inspection 862802 - 2014-01-21
- FDA Inspection 833497 - 2013-05-30
- FDA Inspection 815058 - 2013-01-11
- FDA Inspection 792974 - 2012-08-03
- FDA Inspection 759172 - 2011-12-14
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