FDA Inspection
Lupin Ltd.Lupin Ltd. – FDA Inspection, May 15, 2019
Record Details
This FDA Inspection record concerns Lupin Ltd., with an inspection on May 15, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 0cf322c3-8dfa-45f6-b51d-5ea8fcdc1229
Inspection Facts
- Inspection number
- 1090546
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Lupin Ltd.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| March 15, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 28, 2017 | Not classified | Office of Inspections and Investigations | |
| April 26, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Lupin Ltd.
- FDA Inspection 1280668 - 2025-09-05
- FDA Inspection 1235550 - 2024-03-15
- FDA Inspection 1121188 - 2020-02-14
- FDA Inspection 1024531 - 2017-07-28
- FDA Inspection 1012780 - 2017-04-26
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