FDA inspection

Akeso Biopharma, Co., Ltd.: FDA inspection ending Aug 7, 2023

FDA inspection 1218071 · Official Action Indicated (OAI) · Zhongshan

Key facts

Inspection ID 1218071
Firm Akeso Biopharma, Co., Ltd.
FEI number 3017057933
Address 6 Shennong Road, Torch Development Zone
City Zhongshan
Fiscal year 2023
Inspection end date Aug 7, 2023
Classification Official Action Indicated (OAI)
Project area New Drug Evaluation
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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