Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003809840.
Observations5
Issue DateJanuary 17, 2025
Status1 Related Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Genzyme Ireland Limited
Location
Waterford, -, Ireland
FEI Number
3003809840
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
January 17, 2025
Country
Ireland
Inspection History, 2008 to 2026
NAI2
VAI7
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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