FDA inspection

WINNER MEDICAL CO., LTD.: FDA inspection ending Aug 29, 2019

FDA inspection 1111770 · Voluntary Action Indicated (VAI) · Shenzhen

Key facts

Inspection ID 1111770
Firm WINNER MEDICAL CO., LTD.
FEI number 3005076849
Address Winner Industrial Park, Bulonglu; Baoan
City Shenzhen
Country China
Fiscal year 2019
Inspection end date Aug 29, 2019
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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