Overview
- 18 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
18
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2026 – 6 Feb 2026 | Human Drugs | 483 | View 483 → |
| 18 Sep 2018 – 26 Sep 2018 | Human Drugs | Clean | |
| 27 Aug 2018 – 29 Aug 2018 | Human Drugs | Clean | |
| 8 Feb 2018 – 7 Mar 2018 | Human Drugs | Clean | |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | Clean | |
| 18 Jan 2016 – 28 Jan 2016 | Human Drugs | Clean | |
| 6 May 2015 – 8 May 2015 | Human Drugs | 483 | View 483 → |
| 18 Nov 2013 – 22 Nov 2013 | Human Drugs | Clean | |
| 7 Dec 2012 | Not recorded | Clean | |
| 29 Oct 2010 | Not recorded | Clean | |
| 23 Apr 2010 | Not recorded | 483 | On file |
| 18 Apr 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Feb 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wayne D Mcgrath, JoshRenzo N Ramilo
Investigators
FDA investigators tied to this site in the record.
Allen F Hall2 insp.
John S Hartford2 insp.
Wayne D Mcgrath1 insp.
JoshRenzo N Ramilo1 insp.
Kara A Scheibner1 insp.
Amanda Lewin1 insp.
Roger F Zabinski1 insp.
Susanne M Richardson1 insp.
Mohsen Rajabi Abhari1 insp.
Gajendiran Mahadevan1 insp.
Sherri N Rohlf1 insp.
Alan P Kurtzberg1 insp.
Kirtida Patel1 insp.
Ruben C Ayala1 insp.
Bonita S Chester1 insp.
Kathryn A Krentz1 insp.
Felix Maldonado1 insp.
Kevin A Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Industries Ltd'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