FDA inspection

Suntech Medical, Inc.: FDA inspection ending May 22, 2024

FDA inspection 1239175 · Voluntary Action Indicated (VAI) · Morrisville, NC

Key facts

Inspection ID 1239175
Firm Suntech Medical, Inc.
FEI number 1036863
Address 5827 S Miami Blvd Ste 100
City Morrisville
State NC
ZIP 27560
Country United States
Fiscal year 2024
Inspection end date May 22, 2024
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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