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# Genzyme Ireland Inspection Documents CGMP Issue
- URL: https://www.fdaweb.com/genzyme-ireland-inspection-documents-cgmp-issue/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161398

A 1/12-1/20 FDA inspection at the Genzyme Ireland facility located in County Wexford, Ireland, documented significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genzyme-ireland-limited-728681-06222026?ref=fdaweb.com) says the specific violation was the failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says that while Genzyme’s responses to the form FDA-483 indicated that the company has implemented corrective actions, it failed to address the underlying failure of the quality unit to ensure compliance with CGMP requirements. The response also lacks a comprehensive plan that addresses the root cause of the quality unit’s failure to fulfill its CGMP oversight responsibilities, FDA says.

Genzyme was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation showing that the issues have been addressed and a schedule for completing the corrections.