FDA inspection

Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.: FDA inspection ending Jul 29, 2016

FDA inspection 981948 · Voluntary Action Indicated (VAI) · Wujin, Changzhou

Key facts

Inspection ID 981948
Firm Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
FEI number 3004175957
Address Daixi Street, Wujin District
City Wujin, Changzhou
Country China
Fiscal year 2016
Inspection end date Jul 29, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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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