FDA-Inspected Site

Amphastar Nanjing Pharmaceuticals Inc

7 FDA inspections are on record for Amphastar Nanjing Pharmaceuticals Inc in Nanjing, China.

483· Form 483 issued

Nanjing, China · Last updated July 9, 2026

Overview

  • 7 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-19.

At a glance

Inspections

7

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Sep 2025 – 19 Sep 2025Human Drugs483On file
3 Mar 2025 – 7 Mar 2025Human DrugsClean
7 Oct 2019 – 11 Oct 2019Human Drugs483On file
23 Oct 2017 – 26 Oct 2017Human DrugsClean
24 Apr 2017 – 28 Apr 2017Human Drugs483On file
25 Apr 2016 – 29 Apr 2016Human DrugsClean
31 Mar 2014 – 4 Apr 2014Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Tracey L Harris1 insp.
Gang Wang1 insp.

Full site report

Get the verbatim findings behind Amphastar Nanjing Pharmaceuticals Inc's 4 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