FDA inspection

LeMaitre Vascular, Inc.: FDA inspection ending Apr 16, 2025

FDA inspection 1235542 · Official Action Indicated (OAI) · North Brunswick, NJ

Key facts

Inspection ID 1235542
Firm LeMaitre Vascular, Inc.
FEI number 1000121696
Address 206 N Center Dr
City North Brunswick
State NJ
ZIP 08902
Country United States
Fiscal year 2025
Inspection end date Apr 16, 2025
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 713502

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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