Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-10.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2026 – 10 Feb 2026 | Human Drugs | 483 | On file |
| 28 Jul 2023 – 4 Aug 2023 | Human Drugs | Clean | |
| 2 May 2022 – 10 May 2022 | Human Drugs | 483 | View 483 → |
| 19 Sep 2019 – 27 Sep 2019 | Human Drugs | 483 | On file |
| 19 Jun 2017 – 24 Jun 2017 | Human Drugs | Clean | |
| 25 Jan 2016 – 29 Jan 2016 | Human Drugs | 483 | View 483 → |
| 5 Mar 2015 – 13 Mar 2015 | Human Drugs | Clean | |
| 19 Jun 2012 | Not recorded | Clean | |
| 30 Jul 2010 | Not recorded | 483 | On file |
| 13 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 May 2022
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Justin A Boyd, Darren S Brown
10 May 2022
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Justin A Boyd, Darren S Brown
Investigators
FDA investigators tied to this site in the record.
Guerlain Ulysse1 insp.
Pratik S Upadhyay1 insp.
Nibin Varghese1 insp.
Sangeeta M Khurana1 insp.
Carolina D Vasquez1 insp.
Justin A Boyd1 insp.
Darren S Brown1 insp.
Tamil Arasu1 insp.
Emmanuel J Ramos1 insp.
Jogy George1 insp.
Michele Perry-Williams1 insp.
Doan T Nguyen1 insp.
Toyin B Oladimeji1 insp.
Marvin D Jones1 insp.
Freddy Ortiz Colon1 insp.
Sanket N Patel1 insp.
Pankaj H Amin1 insp.
Matthew B Casale1 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 | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurobindo Pharma Limited's 5 Form 483s
Source PDFs 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