FDA-Inspected Site

Inventia Healthcare Limited

5 FDA inspections are on record for Inventia Healthcare Limited in Thane, India.

483· Form 483 issued

Thane, India · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-12.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Feb 2025 – 12 Feb 2025Human Drugs483On file
1 Jul 2019 – 5 Jul 2019Human Drugs483View 483 →
17 Aug 2015 – 21 Aug 2015Human DrugsClean
6 May 2013 – 10 May 2013Human DrugsClean
3 Dec 2010Not recordedClean

Observations on record

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

5 Jul 2019
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Nicole E Knowlton, Jose A Lopez Rubet

5 Jul 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nicole E Knowlton, Jose A Lopez Rubet

5 Jul 2019
21 CFR 211.194(a)

Complete test data included in records

Cited by Nicole E Knowlton, Jose A Lopez Rubet

5 Jul 2019
21 CFR 211.194(d)

Laboratory equipment calibration records

Cited by Nicole E Knowlton, Jose A Lopez Rubet

5 Jul 2019
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Nicole E Knowlton, Jose A Lopez Rubet

Investigators

FDA investigators tied to this site in the record.

Jose A Lopez Rubet1 insp.
Junho Pak1 insp.
S. L Brown1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Inventia Healthcare Limited's 2 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