Atlas

FDA-Inspected Site

Brightgene Pharmaceutical Co., Ltd.

4 FDA inspections are on record for Brightgene Pharmaceutical Co., Ltd. in Suzhou, China.

483· Form 483 issued

Suzhou, China · Last updated July 9, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-04-26.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Apr 2024 – 26 Apr 2024Human Drugs483On file
4 Dec 2017 – 8 Dec 2017Human DrugsClean
7 Sep 2015 – 10 Sep 2015Human Drugs483On file
11 Mar 2013 – 14 Mar 2013Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Tonia F Bernard1 insp.
Steven P Donald1 insp.
Peter E Baker1 insp.
Kevin A Gonzalez1 insp.

Full site report

Get the verbatim findings behind Brightgene Pharmaceutical 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