Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-06.
At a glance
Inspections
8
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2024 – 6 Sep 2024 | Human Drugs | WL | On file |
| 9 Jan 2023 – 13 Jan 2023 | Human Drugs | 483 | On file |
| 10 Feb 2020 – 14 Feb 2020 | Human Drugs | 483 | View 483 → |
| 19 Mar 2018 – 23 Mar 2018 | Human Drugs | Clean | |
| 10 Oct 2016 – 14 Oct 2016 | Human Drugs | Clean | |
| 10 Mar 2015 – 13 Mar 2015 | Human Drugs | Clean | |
| 13 Sep 2012 | Not recorded | 483 | On file |
| 12 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Feb 2020
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Darren S Brown, Jose A Lopez Rubet
14 Feb 2020
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Darren S Brown, Jose A Lopez Rubet
Investigators
FDA investigators tied to this site in the record.
Pratik S Upadhyay1 insp.
Joseph A Piechocki1 insp.
Jogy George1 insp.
Darren S Brown1 insp.
Jose A Lopez Rubet1 insp.
Debra I Love1 insp.
Xiaohui Shen1 insp.
Steven P Donald1 insp.
Zachary A Bogorad1 insp.
Simone E Pitts1 insp.
Susanna E Ford1 insp.
Pal S Mayasandra1 insp.
Marie F Morin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Granules India Limited's 4 Form 483s
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