Rubicon Research Private Limited FDA Record
Rubicon Research Private Limited has 4 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rubicon Research Private Limited" is on file.
- Latest recall
- D-0659-2024 · Class III · Aug 24, 2024
- Latest inspection
- Mar 20, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 3 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 1 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0659-2024 | Class III | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma… | Aug 24, 2024 |
| D-0517-2024 | Class II | Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC… | May 6, 2024 |
| D-0487-2024 | Class II | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen… | Apr 26, 2024 |
| D-0362-2022 | Class II | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma… | Dec 31, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 20, 2025 | Thane, India | Drugs | No Action Indicated (NAI) | 3006559899 |
- 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 3006559899 | Thane, India | 1 | Mar 20, 2025 |
Rubicon Research Private Limited and the FDA: common questions
Has Rubicon Research Private Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Rubicon Research Private 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 Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "Rubicon Research Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Rubicon Research Private Limited?
The most recent FDA inspection on file ended Mar 20, 2025 at Thane, India and was classified NAI. FDA has 1 inspection of Rubicon Research Private Limited on file.
Has Rubicon Research Private Limited had an FDA recall?
Yes. Rubicon Research Private Limited has 4 FDA recalls on record. The most recent started Aug 24, 2024.
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