FDA-Inspected Site

Zydus Hospira Oncology Private Limited

6 FDA inspections are on record for Zydus Hospira Oncology Private Limited in Matoda, India.

483· Form 483 issued

Matoda, India · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-06-30.

At a glance

Inspections

6

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Jun 2023 – 30 Jun 2023Human Drugs483On file
14 Oct 2019 – 22 Oct 2019Human Drugs483View 483 →
5 Apr 2018 – 12 Apr 2018Human Drugs483On file
8 Sep 2014 – 16 Sep 2014Human DrugsClean
26 Jul 2012Not recordedClean
10 Nov 2009Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

22 Oct 2019
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Junho Pak

22 Oct 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Junho Pak

22 Oct 2019
21 CFR 211.42(c)(10)(vi)

Equipment to control conditions

Cited by Junho Pak

Investigators

FDA investigators tied to this site in the record.

Junho Pak1 insp.
Vilmary Negron Rodriguez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Zydus Hospira Oncology Private Limited's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, 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