FDA Inspection
Granules India LimitedGranules India Limited – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns Granules India Limited, with an inspection on March 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 753771aa-2bd9-4830-8756-bd297cb2cb2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047594
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Granules India Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Granules India Limited
- FDA Inspection 1214734 - 2023-06-23
- FDA Inspection 954648 - 2015-12-18
- FDA Inspection 832632 - 2013-05-08
- FDA Inspection 574854 - 2009-03-06
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