FDA Inspection
Torrent Pharmaceuticals LimitedTorrent Pharmaceuticals Limited – FDA Inspection, Apr 16, 2009
Record Details
This FDA Inspection record concerns Torrent Pharmaceuticals Limited, with an inspection on April 16, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 16, 2009
- Product Type
- Drugs
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ID · d6f06b7d-eeaf-40ea-ba45-4da9946e5ef2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 577760
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Torrent Pharmaceuticals Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 9, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Torrent Pharmaceuticals Limited
- FDA Inspection 1281652 - 2025-08-01
- FDA Inspection 1083416 - 2019-02-08
- FDA Inspection 954887 - 2015-12-11
- FDA Inspection 816720 - 2013-01-09
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