Drug factory · FDA FEI 3003809840
Genzyme Ireland Limited
Unit 701 IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Feb 25, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2008: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Agalsidase Beta | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-0040, 58468-0041 |
| Alglucosidase Alfa | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-0160 |
| Alirocumab | Makes it, tests it, packages it and labels it |
Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC |
61755-020, 61755-021, 0024-5901 +1 |
| Avalglucosidase Alfa | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-0426 |
| Dupilumab | Makes it, tests it, packages it and labels it |
Sanofi-Aventis U.S. LLC |
0024-5914, 0024-5915 |
| Efanesoctocog Alfa | Makes it and tests it |
Bioverativ Therapeutics Inc. |
71104-978, 71104-979, 71104-981 +3 |
| Eliglustat | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-0220 |
| Imiglucerase | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-4663 |
| Lapine T-Lymphocyte Immune Globulin | Makes it, tests it, packages it, labels it and sterilizes it |
Genzyme Corporation |
58468-0080 |
| Olipudase Alfa | Makes it, tests it, packages it and labels it |
Genzyme Corporation |
58468-0050, 58468-0051 |
| Sarilumab | Makes it and tests it |
Sanofi-Aventis U.S. LLC |
0024-5908, 0024-5910 |
| Sevelamer | Makes it, tests it, packages it and labels it |
Genzyme Corporation, Sanofi-Aventis U.S. LLC |
58468-0131, 58468-0132, 58468-0133 +3 |
| Thyrotropin Alfa | Makes it |
Genzyme Corporation |
58468-0030, 58468-1849 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Feb 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 2, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 30, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 30, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2008 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack; sterilize.