Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-27.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 27 Jan 2023 | Human Drugs | Clean | |
| 26 Jul 2022 – 5 Aug 2022 | Human Drugs | 483 | View 483 → |
| 22 Apr 2019 – 3 May 2019 | Human Drugs | WL | View 483 → |
| 18 Mar 2019 – 22 Mar 2019 | Human Drugs | Clean | |
| 5 Feb 2018 – 9 Feb 2018 | Human Drugs | Clean | |
| 31 Aug 2017 – 7 Sep 2017 | Human Drugs | Clean | |
| 6 Feb 2017 – 16 Feb 2017 | Human Drugs | Clean | |
| 28 Aug 2014 – 5 Sep 2014 | Human Drugs | WL | View 483 → |
| 7 Jul 2014 – 10 Jul 2014 | Human Drugs | 483 | On file |
| 8 Aug 2013 – 19 Aug 2013 | Human Drugs | 483 | On file |
| 23 Feb 2012 | Not recorded | 483 | View 483 → |
| 3 Feb 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Dipesh K Shah, Kellia N Hicks
3 May 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Rita K Kabaso, Thomas J Arista
Investigators
FDA investigators tied to this site in the record.
Jared P Stevens1 insp.
Dipesh K Shah1 insp.
Kellia N Hicks1 insp.
Justin A Boyd1 insp.
Rita K Kabaso1 insp.
Thomas J Arista1 insp.
Makini Cobourne-Duval1 insp.
Hasan A Irier1 insp.
Scott T Ballard1 insp.
Brandon C Heitmeier1 insp.
Seneca D Toms1 insp.
Susanna E Ford1 insp.
Zhaoyang Meng1 insp.
Katherine Szestypalow1 insp.
Eric M Mueller1 insp.
Scott B Laufenberg1 insp.
James C Maclaughlin1 insp.
Mural B Gavini1 insp.
Jose A Cruz Gonzalez1 insp.
Ivis L Negron Torres1 insp.
Xiaokuang Lai1 insp.
Susan M Jackson1 insp.
Charles Cote1 insp.
James S Cartwright1 insp.
Steven A Gonzales1 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 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | 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 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | 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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zydus Lifesciences Limited's 7 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