FDA Inspection
Lupin LimitedLupin Limited – FDA Inspection, Jul 17, 2025
Record Details
This FDA Inspection record concerns Lupin Limited, with an inspection on July 17, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 3eb0abd3-7b93-490d-8975-7c91722b0398
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1275680
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Lupin Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2018 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| June 16, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| June 8, 2017 | Not classified | Office of Inspections and Investigations | |
| March 27, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lupin Limited
- FDA Inspection 1069052 - 2018-10-18
- FDA Inspection 1014374 - 2017-06-16
- FDA Inspection 1020760 - 2017-06-08
- FDA Inspection 924395 - 2015-03-27
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