FDA inspection

Henan Kangdi Medical Devices Co. Ltd: FDA inspection ending Dec 14, 2016

FDA inspection 995883 · Voluntary Action Indicated (VAI) · Zhoukou

Key facts

Inspection ID 995883
Firm Henan Kangdi Medical Devices Co. Ltd
FEI number 3009271465
Address Sme Pioneer Park, No. 4; 2nd Area
City Zhoukou
Country China
Fiscal year 2017
Inspection end date Dec 14, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 10–99 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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