Rubicon Research Limited FDA Record
Rubicon Research Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rubicon Research Limited" is on file.
- Latest recall
- D-0659-2024 · Aug 24, 2024 · filed under Rubicon Research Private Limited
- Latest inspection
- Nov 7, 2024 · NAI
Newer recall under related name Rubicon Research Private Limited: Aug 24, 2024, D-0659-2024.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 7, 2024 | Thane, India | Devices | No Action Indicated (NAI) | 3008252295 |
| Mar 8, 2024 | Thane, India | Drugs | No Action Indicated (NAI) | 3008252295 |
| Jan 27, 2023 | Thane, India | Drugs | Voluntary Action Indicated (VAI) | 3008252295 |
| Nov 20, 2017 | Thane, India | Drugs | No Action Indicated (NAI) | 3008252295 |
| Mar 13, 2015 | Thane, India | Drugs | No Action Indicated (NAI) | 3008252295 |
| Apr 11, 2013 | Thane, India | Drugs | Voluntary Action Indicated (VAI) | 3008252295 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008252295 | Thane, India | 6 | Nov 7, 2024 |
Rubicon Research Limited and the FDA: common questions
Has Rubicon Research Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Rubicon Research Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Rubicon Research Limited received an FDA Form 483?
FDA has not published a Form 483 for "Rubicon Research Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Rubicon Research Limited?
The most recent FDA inspection on file ended Nov 7, 2024 at Thane, India and was classified NAI. FDA has 6 inspections of Rubicon Research Limited on file.
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