Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-13.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2025 – 13 Aug 2025 | Human Drugs | 483 | View 483 → |
| 2 Mar 2020 – 9 Mar 2020 | Human Drugs | Clean | |
| 15 Jul 2019 – 19 Jul 2019 | Human Drugs | Clean | |
| 21 Feb 2017 – 1 Mar 2017 | Human Drugs | 483 | On file |
| 18 May 2015 – 23 May 2015 | Human Drugs | 483 | View 483 → |
| 9 Nov 2012 | Not recorded | 483 | View 483 → |
| 8 Oct 2010 | Not recorded | 483 | On file |
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.
Vioela J Caze1 insp.
Joan M Cantellops Figueroa1 insp.
Jolanna A Norton1 insp.
Maria Estrella1 insp.
Nicole E Knowlton1 insp.
Linda F Murphy1 insp.
Liming Zhang1 insp.
Peter E Baker1 insp.
Pankaj H Amin1 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 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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(d) | 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 |
Full site report
Get the verbatim findings behind Zydus Lifesciences 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