Drug factory · FDA FEI 3009107538
Lupin Limited
Unit-3, Plot No. M-1 and M-3-A, Special Economic Zone, Phase - II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Betamethasone | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-947 |
| Clobetasol | Makes it, tests it and packages it | Lupin Pharmaceuticals, Inc. | 43386-028, 43386-096, 68180-536 +1 |
| Desoximetasone | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-944, 68180-946, 68180-948 +2 |
| Diclofenac | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-537 |
| Fluocinonide | Makes it, tests it and packages it | Lupin Pharmaceuticals, Inc. | 43386-026, 43386-095 |
| Hydrocortisone | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-951 |
| Nystatin and Triamcinolone Acetonide | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-545 |
| Testosterone | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-941, 68180-943 |
| Triamcinolone Acetonide | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-945, 68180-952, 68180-953 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2015 | No problems found | 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 that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: manufacture; pack.