FDA-Inspected Site

Lupin Limited

8 FDA inspections are on record for Lupin Limited in Mandideep, India.

483· Form 483 issued

Mandideep, India · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-11-23.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Nov 2022 – 23 Nov 2022Human Drugs483On file
26 Nov 2018 – 4 Dec 2018Human Drugs483On file
8 Feb 2016 – 19 Feb 2016Human Drugs483On file
23 Sep 2011Not recorded483View 483 →
30 Nov 2009Not recorded483On file
12 Nov 2008Not recorded483On file
24 Mar 2003Not recordedClean
24 Feb 2000Not recordedClean

Observations on record

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

23 Sep 2011
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Patric C Klotzbuecher

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Lupin Limited's 6 Form 483s

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