FDA Inspection
Rubicon Research Private LimitedRubicon Research Private Limited – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Rubicon Research Private Limited, with an inspection on August 30, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 55f86403-05fa-4714-9732-5d05f143debb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102226
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Rubicon Research Private Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 8, 2024 | NAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| January 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 20, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rubicon Research Private Limited
- FDA Inspection 1250746 - 2024-11-07
- FDA Inspection 1231826 - 2024-03-08
- FDA Inspection 1195651 - 2023-01-27
- FDA Inspection 1038536 - 2017-11-20
- FDA Inspection 924394 - 2015-03-13
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