Orca1

FDA inspection

Sirtex Wilmington LLC: FDA inspection ending Jul 10, 2025

FDA inspection 1267696 · Voluntary Action Indicated (VAI) · Wilmington, Massachusetts

Key facts

Inspection ID 1267696
Firm Sirtex Wilmington LLC
FEI number 3005579300
Address 16 Upton Dr Unit 2-4
City Wilmington
State Massachusetts
ZIP 01887
Fiscal year 2025
Inspection end date Jul 10, 2025
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical 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.

Other inspections at this establishment

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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