Drug factory · FDA FEI 3007549629
Lupin Limited
Unit-2, Plot No. M-2 and M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, India
Serious problems, FDA action at FDA's last inspection, Jul 17, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2009: 1 with no problems, 1 with problems fixed voluntarily, 4 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2025 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Jan 25, 2019 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| May 19, 2017 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jan 23, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 22, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 17, 2025 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Air Supply 21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Jan 25, 2019 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: manufacture; pack.