FDA Inspection
Zydus Lifesciences LimitedZydus Lifesciences Limited – FDA Inspection, Apr 23, 2024
Record Details
This FDA Inspection record concerns Zydus Lifesciences Limited, with an inspection on April 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3ed9f1d7-7263-433f-bb86-fb9cc83e860f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1236639
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Zydus Lifesciences Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | Not classified | Office of Inspections and Investigations | |
| March 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Zydus Lifesciences Limited
- FDA Inspection 1282790 - 2025-09-05
- FDA Inspection 1164108 - 2022-03-10
- FDA Inspection 1063601 - 2018-08-28
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