FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Aug 26, 2022
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on August 26, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cipla Limited
- Inspection Date
- August 26, 2022
- Product Type
- Drugs
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ID · dc52b0e2-2947-4e2d-9bdf-1a9dc7fb515e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1178952
- 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 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 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 |
| June 21, 2024 | VAI | 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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