Drug factory · FDA FEI 3007543295
Johnson & Johnson Private Limited
Higi House, Opp. Ralli Wolf, L.B.S. Marg, Mulund (W), Mumbai, India
No problems found at FDA's last inspection, Apr 30, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2010: 4 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Tests it | Janssen Biotech, Inc. | 57894-150, 57894-195 |
| Abiraterone and Niraparib | Tests it | Janssen Biotech, Inc. | 57894-050, 57894-100 |
| Apalutamide | Tests it | Janssen Products LP | 59676-600, 59676-604 |
| Canagliflozin and Metformin | Tests it | Janssen Pharmaceuticals, Inc. | 50458-940, 50458-941, 50458-942 +1 |
| Erdafitinib | Tests it | Janssen Products LP | 59676-030, 59676-040, 59676-050 |
| Etravirine | Tests it | Janssen Products LP, Patriot Pharmaceuticals | 59676-570, 59676-571, 59676-572 +2 |
| Gemcitabine | Tests it | Janssen Biotech, Inc. | 57894-225 |
| Icotrokinra | Tests it | Janssen Biotech, Inc. | 57894-201 |
| Lazertinib | Tests it | Janssen Biotech, Inc. | 57894-080, 57894-240 |
| Macitentan | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-501 |
| Macitentan and Tadalafil | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-812, 66215-814 |
| Rilpivirine | Tests it | Janssen Products LP | 59676-280 |
| Rivaroxaban | Tests it | Janssen Pharmaceuticals, Inc. | 50458-575 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 30, 2025 | No problems found | Drug Quality Assurance | — |
| Jul 10, 2019 | No problems found | Drug Quality Assurance | — |
| May 28, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 15, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.