FDA inspection

Iradimed Corporation: FDA inspection ending Oct 19, 2018

FDA inspection 1110893 · Voluntary Action Indicated (VAI) · Winter Springs, FL

Key facts

Inspection ID 1110893
Firm Iradimed Corporation
FEI number 3005053560
Address 1025 Willa Springs Dr
City Winter Springs
State FL
ZIP 32708-5235
Fiscal year 2019
Inspection end date Oct 19, 2018
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None 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

Browse all FDA inspections