FDA inspection
Genzyme Ireland Limited: FDA inspection ending Jan 20, 2026
FDA inspection 1301880 · Official Action Indicated (OAI) · Waterford
Key facts
| Inspection ID | 1301880 |
|---|---|
| Firm | Genzyme Ireland Limited |
| FEI number | 3003809840 |
| Address | Unit 701, Ida Industrial Park; Old Kilmeaden Road |
| City | Waterford |
| Country | Ireland |
| Fiscal year | 2026 |
| Inspection end date | Jan 20, 2026 |
| Classification | Official Action Indicated (OAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
| Warning letter | 728681 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data