Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-14.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2025 – 14 Feb 2025 | Human Drugs | WL | View 483 → |
| 17 Feb 2020 – 25 Feb 2020 | Human Drugs | Clean | |
| 9 Sep 2019 – 13 Sep 2019 | Human Drugs | Clean | |
| 14 May 2018 – 24 May 2018 | Human Drugs | 483 | View 483 → |
| 22 Aug 2017 – 26 Aug 2017 | Human Drugs | Clean | |
| 5 Jul 2017 – 8 Jul 2017 | Human Drugs | Clean | |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | View 483 → |
| 20 Jul 2015 – 24 Jul 2015 | Human Drugs | 483 | On file |
| 21 Oct 2013 – 25 Oct 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Feb 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Saleem A Akhtar
14 Feb 2025
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Tamil Arasu, Saleem A Akhtar
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Saleem A Akhtar1 insp.
Ross J Grigsby1 insp.
Matthew B Casale1 insp.
Arsen Karapetyan1 insp.
Pratik S Upadhyay1 insp.
Constantin Y Philopoulos1 insp.
Hasan A Irier1 insp.
Yasamin Ameri1 insp.
Daniel J Roberts1 insp.
Steven D Kehoe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Glenmark Pharmaceuticals Limited's 5 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