Atlas

FDA-Inspected Site

Akeso Biopharma Co., Ltd.

2 FDA inspections are on record for Akeso Biopharma Co., Ltd. in Zhongshan, China.

483· Form 483 issued

Zhongshan, China · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-04.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Feb 2025 – 4 Mar 2025Human Drugs483On file
25 Jul 2023 – 7 Aug 2023Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Yun Wu2 insp.
Thuy T Nguyen1 insp.
Khalid M Khan1 insp.
Charles Y Kuo1 insp.
Zhong Li1 insp.

Full site report

Get the verbatim findings behind Akeso Biopharma Co., Ltd.'s 2 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat