FDA inspection

Genzyme Ireland Limited: FDA inspection ending Jan 17, 2025

FDA inspection 1260340 · Official Action Indicated (OAI) · Waterford

Key facts

Inspection ID 1260340
Firm Genzyme Ireland Limited
FEI number 3003809840
Address IDA Industrial Park, Unit 701, Old Kilmeaden Road
City Waterford
Fiscal year 2025
Inspection end date Jan 17, 2025
Classification Official Action Indicated (OAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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