FDA Inspection
Lupin LimitedLupin Limited – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Lupin Limited, with an inspection on June 16, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Doan N. Singh (Issuing Officer)
- Zhigang Sun (Issuing Officer)
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ID · 01c316a2-7af0-49ff-8e17-c771a1cd03fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014374
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Lupin Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| October 18, 2018 | OAI | Center for Drug Evaluation and Research | 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 1275680 - 2025-07-17
- FDA Inspection 1069052 - 2018-10-18
- FDA Inspection 1020760 - 2017-06-08
- FDA Inspection 924395 - 2015-03-27
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