FDA inspection

Sirtex Wilmington LLC: FDA inspection ending Jan 30, 2009

FDA inspection 578579 · Voluntary Action Indicated (VAI) · Wilmington, MA

Key facts

Inspection ID 578579
Firm Sirtex Wilmington LLC
FEI number 3005579300
Address 16 Upton Dr Unit 2-4
City Wilmington
State MA
ZIP 01887
Country United States
Fiscal year 2009
Inspection end date Jan 30, 2009
Classification Voluntary Action Indicated (VAI)
Project area Project Evaluation: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 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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