FDA Inspection
Zydus Lifesciences LimitedZydus Lifesciences Limited – FDA Inspection, May 5, 2026
Record Details
This FDA Inspection record concerns Zydus Lifesciences Limited, with an inspection on May 5, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 4d04c5ac-f0e2-4892-b6c4-cb466ec76340
Inspection Facts
- Inspection number
- 1319032
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zydus Lifesciences Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2026 | Not classified | Office of Inspections and Investigations | |
| June 13, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Zydus Lifesciences Limited
- FDA Inspection 1309202 - 2026-02-19
- FDA Inspection 1211021 - 2023-06-13
- FDA Inspection 1066839 - 2018-08-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.