FDA inspection

Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant): FDA inspection ending Mar 22, 2019

FDA inspection 1084107 · Voluntary Action Indicated (VAI) · Wenzhou

Key facts

Inspection ID 1084107
Firm Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
FEI number 3010728912
Address Economic & Technological Development Zon, NO. 555 the 8th Binhai Rd., Binhai Indus
City Wenzhou
Country China
Fiscal year 2019
Inspection end date Mar 22, 2019
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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