Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-12.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Aug 2022 – 12 Aug 2022 | Human Drugs | 483 | View 483 → |
| 3 Feb 2020 – 7 Feb 2020 | Human Drugs | 483 | View 483 → |
| 6 May 2019 – 10 May 2019 | Human Drugs | Clean | |
| 10 Sep 2018 – 14 Sep 2018 | Human Drugs | 483 | On file |
| 7 Nov 2016 – 16 Nov 2016 | Human Drugs | 483 | On file |
| 12 Dec 2012 | Not recorded | 483 | On file |
| 26 Sep 2012 | Not recorded | 483 | On file |
| 29 Mar 2008 | Not recorded | Clean | |
| 2 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2022
21 CFR 211.100(a)
Approval and review of procedures
Cited by Justin A Boyd, Teresa I Navas, Jonah S Ufferfilge
12 Aug 2022
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Justin A Boyd, Teresa I Navas, Jonah S Ufferfilge
12 Aug 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Teresa I Navas, Jonah S Ufferfilge
12 Aug 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Justin A Boyd, Teresa I Navas, Jonah S Ufferfilge
12 Aug 2022
21 CFR 211.194(a)(4)
Complete Test Data
Cited by Justin A Boyd, Teresa I Navas, Jonah S Ufferfilge
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Teresa I Navas1 insp.
Jonah S Ufferfilge1 insp.
Jeffrey P Raimondi1 insp.
Philip F Istafanos1 insp.
Arsen Karapetyan1 insp.
Nicole E Knowlton1 insp.
Maotang Zhou1 insp.
Felix Maldonado1 insp.
Steven D Kehoe1 insp.
Daniel J Roberts1 insp.
Scott B Laufenberg1 insp.
Mural B Gavini1 insp.
Michael A Charles1 insp.
Gayle S Lawson1 insp.
Sarah E Mcmullen1 insp.
Susanna E Ford1 insp.
Jose R Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | 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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Industries Limited's 6 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