FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on June 23, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 8d1e8e30-55f5-46d8-9263-32aedd2aef4f
Inspection Facts
- Inspection number
- 1019068
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.87Retest of approved components/containers/closures
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Other FDA inspections of Cipla Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2026 | Not classified | Office of Inspections and Investigations | |
| February 17, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Cipla Limited
- FDA Inspection 1331746 - 2026-08-25
- FDA Inspection 1198343 - 2023-02-17
- FDA Inspection 1094880 - 2019-05-17
- FDA Inspection 1048005 - 2018-04-13
- FDA Inspection 1007876 - 2017-01-27
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