FDA Inspection
Zydus Lifesciences LimitedZydus Lifesciences Limited – FDA Inspection, Jan 24, 2017
Record Details
This FDA Inspection record concerns Zydus Lifesciences Limited, with an inspection on January 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b1571d81-8218-499b-a956-b8ca74affdce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005475
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Zydus Lifesciences Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 2, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zydus Lifesciences Limited
- FDA Inspection 1204321 - 2023-03-24
- FDA Inspection 1085026 - 2019-04-02
- FDA Inspection 958305 - 2016-01-22
- FDA Inspection 918141 - 2015-02-27
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