Atlas

FDA-Inspected Site

Shanghai Henlius Biologics Co., Ltd.

3 FDA inspections are on record for Shanghai Henlius Biologics Co., Ltd. in Shanghai, China.

483· Form 483 issued

Shanghai, China · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-11.

At a glance

Inspections

3

Form 483s

3

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Feb 2025 – 11 Mar 2025Human Drugs483On file
16 Jan 2025 – 24 Jan 2025Human Drugs483On file
26 Jul 2023 – 4 Aug 2023Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Bo Chi1 insp.
Qiao Y Bobo1 insp.
Liqun Zhao1 insp.
Zhong Li1 insp.
Ralph M Bernstein1 insp.
Gunther H Boekhoudt1 insp.
Michael Shanks1 insp.

Full site report

Get the verbatim findings behind Shanghai Henlius Biologics Co., Ltd.'s 3 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