Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-05.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 5 May 2026 | Human Drugs | 483 | View 483 → |
| 16 Feb 2026 – 19 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 5 Jun 2023 – 13 Jun 2023 | Human Drugs | Clean | |
| 14 Aug 2018 – 24 Aug 2018 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 May 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Brandy N Lepage, Jessica S Estriplet
5 May 2026
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Brandy N Lepage, Jessica S Estriplet
5 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Brandy N Lepage, Jessica S Estriplet
5 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Brandy N Lepage, Jessica S Estriplet
5 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brandy N Lepage, Jessica S Estriplet
Investigators
FDA investigators tied to this site in the record.
Brandy N Lepage1 insp.
Jessica S Estriplet1 insp.
Esteban Beltran1 insp.
Truong X Nguyen1 insp.
Angela E Glenn1 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | 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 1 Form 483
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