FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on January 25, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ac13c1ad-7aa6-454a-ac2a-2a7359de4c28
Inspection Facts
- Inspection number
- 1039322
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| June 21, 2024 | VAI | Center for Drug Evaluation and Research | 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 |
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