Drug factory · FDA FEI 3004995645
Lupin Limited
A 28-1, MIDC Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, India
Problems found, fixed voluntarily at FDA's last inspection, Mar 15, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amlodipine | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-233, 68180-455, 68180-719 +5 |
| Hydroxychloroquine | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-120 |
| Lorazepam | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-347 |
| Meloxicam | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-188, 68180-189 |
| Oseltamivir Acid | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-678 |
| Ramiprilat | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-588, 68180-589, 68180-590 +1 |
| Rifampin | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-658, 68180-659 |
| Rivaroxaban | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-709, 70748-355 |
| Sertraline | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-351, 68180-352, 68180-353 |
| Silodosin | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 68180-740, 68180-741 |
| Sulfamethoxazole and Trimethoprim | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 70748-134 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2020 | No problems found | Drug Quality Assurance | — |
| Apr 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 27, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2009 | 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.
Apr 3, 2015 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established sampling plans are not followed and documented at the time of performance. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: manufacture; pack.