Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Sanofi. FDA records under its name, each linked to the record. See the Sanofi group view.
As of Nov 15, 2026, FDA's public records list Genzyme Ireland with 1 warning letter. The most recent is a warning letter dated Jun 22, 2026: Warning letter: Data integrity, Cleaning validation, Environmental monitoring.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 22, 2026 | Warning letter: Data integrity, Cleaning validation, Environmental monitoringCBER | Warning letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
