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FDA Inspection
•Genzyme Ireland Limited•January 17, 2025

Genzyme Ireland Limited – FDA Inspection, Jan 17, 2025

Record Details

This FDA Inspection record concerns Genzyme Ireland Limited, with an inspection on January 17, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Genzyme Ireland Limited
Inspection Date
January 17, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
People
  • Andrea Franco (Investigator)
  • Wayne E. Seifert (Senior Regulatory Specialist)
View Company Profile

ID · ba9188c1-471f-4911-b37b-a4d7ce0216a8

Inspection Facts

Inspection number
1260340
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Genzyme Ireland Limited

11
DateClassificationOfficeProject area
January 20, 2026Not classifiedOffice of Inspections and Investigations
February 25, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 5, 2018Not classifiedOffice of Inspections and Investigations
February 16, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 16, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 11 other inspections on the company page
Other documents for Genzyme Ireland Limited
  • FDA Inspection 1301880 - 2026-01-20
  • FDA Inspection 1174738 - 2022-02-25
  • FDA Inspection 1074857 - 2018-12-05
  • FDA Inspection 1050839 - 2018-02-16
  • FDA Inspection 1015545 - 2017-06-16

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