Warning letter
Genzyme Ireland Limited: warning letter of Jun 22, 2026
FDA warning letter 728681 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 728681 |
|---|---|
| Company | Genzyme Ireland Limited |
| Subject | CGMP/Deviations/Biologics License Application (BLA) |
| Issue date | Jun 22, 2026 |
| Posted date | Jun 30, 2026 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 211.22, 211.192, 211.194(a) |
| Inspection city | Waterford |
| Inspection start date | Jan 12, 2026 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: