FDA inspection

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: FDA inspection ending Aug 15, 2025

FDA inspection 1281150 · Official Action Indicated (OAI) · Xiamen

Key facts

Inspection ID 1281150
Firm Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
FEI number 3027976266
Address No. 2018, 2 Jietou Road
City Xiamen
Country China
Fiscal year 2025
Inspection end date Aug 15, 2025
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 719320

At a glance

  • None Citations
  • 1–9 Posted citations
  • Yes 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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