Atlas

FDA-Inspected Site

Glenmark Pharmaceuticals Limited

10 FDA inspections are on record for Glenmark Pharmaceuticals Limited in Colvale, India.

483· Form 483 issued

Colvale, India · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-05-20.

At a glance

Inspections

10

Form 483s

9

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 May 2022 – 20 May 2022Human DrugsWLView 483 →
23 Sep 2019 – 27 Sep 2019Human Drugs483View 483 →
7 Mar 2019 – 15 Mar 2019Human Drugs483View 483 →
20 Mar 2017 – 31 Mar 2017Human Drugs483On file
26 May 2014 – 30 May 2014Human DrugsClean
23 Sep 2013 – 25 Sep 2013Human Drugs483On file
15 Jul 2013 – 19 Jul 2013Human Drugs483View 483 →
12 Oct 2011Not recorded483On file
20 Nov 2009Not recorded483On file
23 May 2008Not recorded483On file

Observations on record

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

20 May 2022
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Justin A Boyd, Jose M Cayuela

20 May 2022
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Justin A Boyd, Jose M Cayuela

20 May 2022
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Justin A Boyd, Jose M Cayuela

20 May 2022
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Justin A Boyd, Jose M Cayuela

20 May 2022
21 CFR 211.63

Equipment Design, Size and Location

Cited by Justin A Boyd, Jose M Cayuela

Investigators

FDA investigators tied to this site in the record.

Jose A Lopez Rubet2 insp.
Justin A Boyd1 insp.
Jose M Cayuela1 insp.
Michele L Glendenning1 insp.
Sandra A Hughes1 insp.
Sandra A Boyd1 insp.
Libia M Lugo1 insp.
Dennis Cantellops Paite1 insp.
Michael A Taylor1 insp.
Katherine Szestypalow1 insp.
Scott B Laufenberg1 insp.
Anita Narula1 insp.
Yumi J Hiramine1 insp.
Ramon A Hernandez1 insp.
Matthew B Casale1 insp.
Randy L Self1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.67(a)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Glenmark Pharmaceuticals Limited's 9 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