FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Feb 17, 2023
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on February 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 69b7c844-7159-454b-b581-1a728cf834a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1198343
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
8- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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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 | |
| 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 |
| June 23, 2017 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
| January 27, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Cipla Limited
- FDA Inspection 1331746 - 2026-08-25
- FDA Inspection 1094880 - 2019-05-17
- FDA Inspection 1048005 - 2018-04-13
- FDA Inspection 1019068 - 2017-06-23
- FDA Inspection 1007876 - 2017-01-27
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