Drug factory · FDA FEI 3002807079
Glaxo Wellcome Manufacturing Pte. Ltd
1, Pioneer Sector 1, Jurong, Singapore
Problems found, fixed voluntarily at FDA's last inspection, Oct 13, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cabotegravir and Rilpivirine | Makes the active ingredient and tests it | ViiV Healthcare Company | 49702-240, 49702-253 |
| Naproxen and Sumatriptan | Makes the active ingredient and tests it | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 42847-850 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 2, 2022 | No problems found | Drug Quality Assurance | — |
| Jun 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 16, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 13, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; particle size reduction.