Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2025 – 19 Sep 2025 | Human Drugs | 483 | On file |
| 19 Feb 2024 – 27 Feb 2024 | Human Drugs | 483 | On file |
| 3 Jul 2023 – 13 Jul 2023 | Human Drugs | 483 | View 483 → |
| 28 Jan 2019 – 5 Feb 2019 | Human Drugs | 483 | View 483 → |
| 13 Nov 2017 – 17 Nov 2017 | Human Drugs | 483 | On file |
| 4 Aug 2017 – 11 Aug 2017 | Human Drugs | Clean | |
| 29 May 2017 – 2 Jun 2017 | Human Drugs | Clean | |
| 25 Jan 2016 – 28 Jan 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jul 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Anastasia M Shields, Andrew Le
Investigators
FDA investigators tied to this site in the record.
Eileen A Liu1 insp.
Claudia M Perez-Kasmarski1 insp.
Junho Pak1 insp.
Feiyan Jin1 insp.
Anastasia M Shields1 insp.
Andrew Le1 insp.
Tamil Arasu1 insp.
Makini Cobourne-Duval1 insp.
Melkamu Getie Kebtie1 insp.
Christopher D Leach1 insp.
Anita Narula1 insp.
Debra I Love1 insp.
Nicholas A Violand1 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 |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Medicare 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