Drug factory · FDA FEI 3003623839
Genzyme Flanders
Cipalstraat 8, Geel, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2011: 5 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alglucosidase Alfa | Makes it, makes the active ingredient and tests it | Genzyme Corporation | 58468-0160 |
| Avalglucosidase Alfa | Makes the active ingredient and tests it | Genzyme Corporation | 58468-0426 |
| Efanesoctocog Alfa | Makes the active ingredient and tests it | Bioverativ Therapeutics Inc. | 71104-978, 71104-979, 71104-981 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 15, 2022 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 30, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 22, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 22, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 22, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 24, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.