FDA Inspection
Cipla, Ltd.Cipla, Ltd. – FDA Inspection, Nov 30, 2018
Record Details
This FDA Inspection record concerns Cipla, Ltd., with an inspection on November 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b1e0ddaa-e91a-4c49-ad50-4b8628dd7563
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073182
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Cipla, Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 1, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cipla, Ltd.
- FDA Inspection 1236690 - 2024-05-08
- FDA Inspection 1084973 - 2019-03-20
- FDA Inspection 997481 - 2016-12-09
- FDA Inspection 882706 - 2014-05-23
- FDA Inspection 755727 - 2011-12-01
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