FDA inspection

Dragon Heart Medical Devices Co., Ltd.: FDA inspection ending Jul 21, 2017

FDA inspection 1027744 · Voluntary Action Indicated (VAI) · Kaiping

Key facts

Inspection ID 1027744
Firm Dragon Heart Medical Devices Co., Ltd.
FEI number 3004215921
Address 38 Wujin Road, Baihe Town
City Kaiping
Country China
Fiscal year 2017
Inspection end date Jul 21, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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

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