FDA Inspection
Jubilant Generics LimitedJubilant Generics Limited – FDA Inspection, Aug 8, 2018
Record Details
This FDA Inspection record concerns Jubilant Generics Limited, with an inspection on August 8, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · f029ebb7-21d6-44c6-bb19-4f14e4a00714
Inspection Facts
- Inspection number
- 1061441
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of Jubilant Generics Limited
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | OAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| February 2, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 1, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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