Drug factory · FDA FEI 3003091951
Sanofi-Aventis Singapore Pte. Ltd.
61 Gul Circle, Singapore, Singapore
Problems found, fixed voluntarily at FDA's last inspection, Jun 13, 2025.
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 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Enoxaparin | Makes the active ingredient and tests it | Fresenius Kabi, LLC, Sanofi-Aventis U.S. LLC | 63323-531, 63323-533, 63323-535 +29 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 1, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 9, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.