Company
IrelandGenzyme Ireland Limited, Waterford, Ireland – FDA Inspections
Inspection records and compliance data for Genzyme Ireland Limited in Waterford. 12 FDA inspections on record, 3 Form 483s, 1 warning letter, last inspected January 20, 2026.
Company Profile
This profile covers Genzyme Ireland Limited based in Waterford, Ireland.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 7
- NAI
- 2
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 1
First inspected November 20, 2008. Last inspected January 20, 2026.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 20, 2026 | Not classified | Biologics | 1301880 |
| January 17, 2025 | Not classified | Human Drugs | 1260340 |
| February 25, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1174738 |
| December 5, 2018 | Not classified | Human Drugs | 1074857 |
| February 16, 2018 | NAI | Biologics · Blood and Blood Products | 1050839 |
| June 16, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1015545 |
| September 2, 2015 | VAI | Biologics, Human Drugs · Blood and Blood Products | 944237 |
| September 26, 2013 | VAI | Biologics · Blood and Blood Products | 907153 |
| July 30, 2013 | VAI | Human Drugs · Drug Quality Assurance | 854744 |
| September 30, 2011 | VAI | Human Drugs · Drug Quality Assurance | 751377 |
| October 30, 2009 | VAI | Human Drugs · Drug Quality Assurance | 638081 |
| November 20, 2008 | NAI | Human Drugs · Drug Quality Assurance | 554262 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genzyme Ireland Limited
FEI Number
3003809840
Address
Unit 701, Ida Industrial Par; Old Kilmeaden Road, Waterford, Ireland
Country
Ireland
ID: ef7d4e3c-6fab-4fc3-82f7-354e88ff3aae