FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on September 27, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8e4dda74-73d5-4f2e-853a-19cf3d2511d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1103305
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(b)(2)Sampling/testing of in-process materials
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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 |
| 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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