FDA inspection

Genzyme Ireland Limited: FDA inspection ending Sep 26, 2013

FDA inspection 907153 · Voluntary Action Indicated (VAI) · Waterford

Key facts

Inspection ID 907153
Firm Genzyme Ireland Limited
FEI number 3003809840
Address Unit 701, Ida Industrial Par; Old Kilmeaden Road
City Waterford
Country Ireland
Fiscal year 2013
Inspection end date Sep 26, 2013
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

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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