Atlas

FDA-Inspected Site

Syngene International Limited

6 FDA inspections are on record for Syngene International Limited in Bengaluru, India.

483· Form 483 issued

Bengaluru, India · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-02-20.

At a glance

Inspections

6

Form 483s

1

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2025 – 20 Feb 2025Human Drugs483On file
7 Nov 2022 – 15 Nov 2022Animal Drugs & FeedsClean
19 Aug 2019 – 21 Aug 2019Human DrugsClean
23 Apr 2018 – 27 Apr 2018Human DrugsClean
7 Jul 2014 – 11 Jul 2014Human DrugsClean
16 Sep 2013 – 18 Sep 2013Human DrugsClean

Investigators

FDA investigators tied to this site in the record.

Marcellinus D Dordunoo1 insp.
Dennis Cantellops Paite1 insp.
Robert M Barbosa1 insp.
Lata C Mathew1 insp.
Steven D Kehoe1 insp.
Peter E Baker1 insp.

Full site report

Get the verbatim findings behind Syngene International Limited's 1 Form 483

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