Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-13.
At a glance
Inspections
10
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2025 – 13 Nov 2025 | Human Drugs | 483 | View 483 → |
| 9 Jun 2025 – 17 Jun 2025 | Human Drugs | 483 | On file |
| 18 Mar 2024 – 27 Mar 2024 | Human Drugs | 483 | View 483 → |
| 27 Jan 2020 – 4 Feb 2020 | Human Drugs | Clean | |
| 18 Mar 2019 – 26 Mar 2019 | Human Drugs | 483 | View 483 → |
| 19 Mar 2019 – 21 Mar 2019 | Human Drugs | 483 | On file |
| 28 May 2018 – 5 Jun 2018 | Human Drugs | Clean | |
| 9 Apr 2015 – 17 Apr 2015 | Human Drugs | 483 | View 483 → |
| 23 Jan 2014 – 31 Jan 2014 | Human Drugs | 483 | View 483 → |
| 4 Oct 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Guerlain Ulysse, Rafeeq A Habeeb
13 Nov 2025
21 CFR 211.192
Written record of investigation incomplete
Cited by Guerlain Ulysse, Rafeeq A Habeeb
27 Mar 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sean R Marcsisin, Lori M Newman
27 Mar 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Sean R Marcsisin, Lori M Newman
27 Mar 2024
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Sean R Marcsisin, Lori M Newman
Investigators
FDA investigators tied to this site in the record.
Guerlain Ulysse1 insp.
Rafeeq A Habeeb1 insp.
Jose E Melendez1 insp.
Clinton J Lott1 insp.
Sean R Marcsisin1 insp.
Lori M Newman1 insp.
Felix Maldonado1 insp.
Matthew B Casale1 insp.
Hasan A Irier1 insp.
Kham Phommachanh1 insp.
Debra I Love1 insp.
Eileen A Liu1 insp.
Sony Mathews1 insp.
Edmund F Mrak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zydus Lifesciences Limited's 8 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