FDA inspection

DeGen Medical Inc.: FDA inspection ending Aug 29, 2019

FDA inspection 1101189 · Voluntary Action Indicated (VAI) · Florence, SC

Key facts

Inspection ID 1101189
Firm DeGen Medical Inc.
FEI number 3010663372
Address 1321c N Cashua Dr
City Florence
State SC
ZIP 29501
Country United States
Fiscal year 2019
Inspection end date Aug 29, 2019
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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