FDA Inspection
Zydus Lifesciences LimitedZydus Lifesciences Limited – FDA Inspection, Mar 26, 2019
Record Details
This FDA Inspection record concerns Zydus Lifesciences Limited, with an inspection on March 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ab2f9a14-aaf5-4a0a-b22f-42b04e0882d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083911
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Zydus Lifesciences Limited
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2025 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| June 17, 2025 | Not classified | Office of Inspections and Investigations | |
| March 27, 2024 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| February 4, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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