FDA inspection

XuZhou Kernel Medical Instrument Equipment Co. Ltd: FDA inspection ending Nov 12, 2015

FDA inspection 955604 · Voluntary Action Indicated (VAI) · Xuzhou

Key facts

Inspection ID 955604
Firm XuZhou Kernel Medical Instrument Equipment Co. Ltd
FEI number 3008393409
Address Kernel Mansion, Jinshanqiao Economic; Dev. District
City Xuzhou
Country China
Fiscal year 2016
Inspection end date Nov 12, 2015
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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