Overview
- 13 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
13
Form 483s
11
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2025 – 13 Jun 2025 | Human Drugs | 483 | View 483 → |
| 26 Apr 2022 – 9 May 2022 | Human Drugs | WL | View 483 → |
| 3 Dec 2019 – 13 Dec 2019 | Human Drugs | 483 | View 483 → |
| 3 Jun 2019 – 11 Jun 2019 | Human Drugs | 483 | View 483 → |
| 27 Nov 2018 – 6 Dec 2018 | Human Drugs | Clean | |
| 27 Aug 2018 – 31 Aug 2018 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 23 Feb 2018 | Human Drugs | 483 | View 483 → |
| 17 Nov 2016 – 1 Dec 2016 | Human Drugs | 483 | On file |
| 8 Sep 2014 – 16 Sep 2014 | Human Drugs | WL | On file |
| 28 Sep 2012 | Not recorded | 483 | On file |
| 13 Jun 2012 | Not recorded | 483 | On file |
| 7 Apr 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Lisa L Flores, Pratik S Upadhyay
13 Jun 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Lisa L Flores, Pratik S Upadhyay
13 Jun 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Lisa L Flores, Pratik S Upadhyay
13 Jun 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Lisa L Flores, Pratik S Upadhyay
13 Jun 2025
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Justin A Boyd, Lisa L Flores, Pratik S Upadhyay
Investigators
FDA investigators tied to this site in the record.
Parul M Patel3 insp.
Kellia N Hicks2 insp.
Justin A Boyd1 insp.
Lisa L Flores1 insp.
Pratik S Upadhyay1 insp.
Jose M Cayuela1 insp.
Saleem A Akhtar1 insp.
Ileana Barreto-Pettit1 insp.
Jose E Melendez1 insp.
Dongping Dai1 insp.
Farhana Khan1 insp.
Rebecca E Dombrowski1 insp.
Monica C Burgos Garcia1 insp.
Kejun Cheng1 insp.
Vilmary Negron Rodriguez1 insp.
Angela E Glenn1 insp.
Sarah Ibrahim1 insp.
Scott T Ballard1 insp.
Santos E Camara1 insp.
Patric C Klotzbuecher1 insp.
Thomas J Arista1 insp.
Daniel J Roberts1 insp.
Azza Talaat1 insp.
Scott B Laufenberg1 insp.
Mural B Gavini1 insp.
Walden H Lee1 insp.
Barbara J Breithaupt1 insp.
Simone E Pitts1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(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 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Industries Ltd.'s 11 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