Drug factory · FDA FEI 3005343793
Teva API India Private Ltd.
Plot No. A-2, A-2/1, A-2/2 UPSIDC Industrial Area, Bijnor Road, Gajraula, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 18, 2023.
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: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Risperidone | Tests it | Indivior Inc. | 12496-0090, 12496-0120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 1, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 20, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.