Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-15.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2023 – 15 Dec 2023 | Human Drugs | WL | View 483 → |
| 22 Mar 2019 – 29 Mar 2019 | Human Drugs | 483 | View 483 → |
| 6 Apr 2017 – 13 Apr 2017 | Human Drugs | 483 | On file |
| 27 Jan 2015 – 30 Jan 2015 | Human Drugs | 483 | On file |
| 6 May 2013 – 10 May 2013 | Human Drugs | Clean | |
| 17 Jun 2011 | Not recorded | Clean | |
| 11 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Pratik S Upadhyay1 insp.
Angela E Glenn1 insp.
Cheryl A Clausen1 insp.
Sony Mathews1 insp.
Daniel J Roberts1 insp.
Michael R Goga1 insp.
Azza Talaat1 insp.
Yumi J Hiramine1 insp.
Luis M Burgos Medero1 insp.
Shirley J Berryman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Industries Limited's 4 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