Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-05.
At a glance
Inspections
4
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 5 Sep 2025 | Human Drugs | 483 | On file |
| 15 Apr 2024 – 23 Apr 2024 | Human Drugs | WL | View 483 → |
| 24 Feb 2022 – 10 Mar 2022 | Human Drugs | 483 | View 483 → |
| 20 Aug 2018 – 28 Aug 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Justin A Boyd
23 Apr 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Anastasia M Shields, Justin A Boyd
23 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields, Justin A Boyd
23 Apr 2024
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anastasia M Shields, Justin A Boyd
23 Apr 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Anastasia M Shields, Justin A Boyd
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Damaris Y Hernandez1 insp.
Angelica M Hernandez1 insp.
Anastasia M Shields1 insp.
Justin A Boyd1 insp.
Saleem A Akhtar1 insp.
Satheesh Thomas1 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 | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | 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 211.192 | 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)(iv) | 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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zydus Lifesciences Limited's 4 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