FDA inspection

Tonglu Medical Instrument Co. Ltd.: FDA inspection ending Jun 2, 2016

FDA inspection 978118 · Voluntary Action Indicated (VAI) · Hangzhou

Key facts

Inspection ID 978118
Firm Tonglu Medical Instrument Co. Ltd.
FEI number 3006517555
Address Industrial Park Jiangnan, No. 246 Yangtang Road,
City Hangzhou
Country China
Fiscal year 2016
Inspection end date Jun 2, 2016
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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