Genzyme Ireland Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Ireland
- Registered address
- Unit 701 IDA Industrial Park, Old Kilmeaden Road, Waterford, X91 TP27, Ireland (IRL)
- Operations here
- analysislabelmanufacturepackrelabelrepacksterilize
- FDA identifiers
- FEI 3003809840 · DUNS 985127419
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-02-25
- NAIBlood and Blood Products2018-02-16
- VAIDrug Quality Assurance2017-06-16
- VAIBlood and Blood Products2015-09-02
- VAIDrug Quality Assurance2015-09-02
- VAIBlood and Blood Products2013-09-26
- VAIDrug Quality Assurance2013-07-30
- VAIDrug Quality Assurance2011-09-30
- VAIDrug Quality Assurance2009-10-30
- NAIDrug Quality Assurance2008-11-20
Drugs this plant is listed as making
13 distinct drugs across 27 products name this site in their FDA label.
- Agalsidase BetaGenzyme Corporation
- Alglucosidase AlfaGenzyme Corporation
- alirocumabSanofi-Aventis U.S. LLC
- Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtlBioverativ Therapeutics Inc.
- avalglucosidase alfa-ngptGenzyme Corporation
- DupilumabSanofi-Aventis U.S. LLC
- eliglustatGenzyme Corporation
- ImigluceraseGenzyme Corporation
- olipudase alfa-rpcpGenzyme Corporation
- sarilumabSanofi-Aventis U.S. LLC
- Sevelamer CarbonateSanofi-Aventis U.S. LLC
- Thyrotropin AlfaGenzyme Corporation
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.