FDA Inspection
Jubilant Generics LimitedJubilant Generics Limited – FDA Inspection, Nov 6, 2019
Record Details
This FDA Inspection record concerns Jubilant Generics Limited, with an inspection on November 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Jubilant Generics Limited
- Inspection Date
- November 6, 2019
- Product Type
- Drugs
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ID · 5255e726-231c-487a-93fa-bc1045ac387a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1112459
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
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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 |
| August 8, 2018 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
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