FDA establishment 3003809840, Waterford, Ireland. Part of Genzyme Ireland's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 20, 2026 | Biologics · Blood and Blood Products | None posted | Official Action Indicated (OAI) |
| Feb 25, 2022 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Feb 16, 2018 | Biologics · Blood and Blood Products | None posted | No Action Indicated (NAI) |
| Jun 16, 2017 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Sep 2, 2015 | Drugs · Drug Quality AssuranceBiologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Sep 26, 2013 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Jul 30, 2013 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Sep 30, 2011 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Oct 30, 2009 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Nov 20, 2008 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Product | Charges | Latest |
|---|---|---|
| DUPILUMABOther · 58ACY02 | Sep 3, 2025 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Waterford, Ireland. Part of