FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Jun 21, 2024
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on June 21, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8bbdb860-88af-47ff-ac3a-04cb8bedbcad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240813
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Cipla Limited
13| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| August 26, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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