Company
IndiaLupin Limited, Pithampur, India – FDA Inspections
Inspection records and compliance data for Lupin Limited in Pithampur. 5 FDA inspections on record (1 OAI), 3 Form 483s, last inspected July 17, 2025.
Company Profile
This profile covers Lupin Limited based in Pithampur, India.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected March 27, 2015. Last inspected July 17, 2025.
Most cited issue areas
- Computer control of master formula records2 inspections
- Control procedures to monitor and validate performance2 inspections
- Investigations of discrepancies, failures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1275680 |
| October 18, 2018 | OAI | Human Drugs · Generic Drug Evaluation | 1069052 |
| June 16, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1014374 |
| June 8, 2017 | Not classified | Human Drugs | 1020760 |
| March 27, 2015 | NAI | Human Drugs · Drug Quality Assurance | 924395 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lupin Limited
FEI Number
3009107538
Address
Unit 3, Plot No. M-1, Sez, Phase Ii, Misc Zone, Apperal Park, Dist Dhar, Pithampur, India
Country
India
ID: d2616722-956d-4898-88a7-c22b7bd321a2