FDA-Inspected Site

Serum Institute of India Private Ltd.

3 FDA inspections are on record for Serum Institute of India Private Ltd. in Pune, India.

483· Form 483 issued

Pune, India · 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 2026-01-30.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Jan 2026 – 30 Jan 2026Biologics483On file
24 Jun 2024 – 2 Jul 2024Biologics483On file
11 Apr 2022 – 19 Apr 2022Biologics483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Serum Institute of India Private 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