USV Private Limited
FDA Regulatory Profile
USV Private Limited has 1 FDA recall, 18 inspections, 0 510(k) clearances and 2 compliance actions on record.
- Latest recall
- D-0034-2026 · Class II · Oct 9, 2025
- Latest inspection
- Apr 17, 2026 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 18 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0034-2026 | Class II | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured… | Oct 9, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 17, 2026 | Dabhel, Daman, India | Drugs | Official Action Indicated (OAI) | 3004086192 |
| Sep 12, 2025 | Takula Khed, Dist. Ratnagiri, India | Drugs | Voluntary Action Indicated (VAI) | 3002977798 |
| Nov 17, 2022 | Dabhel, Daman, India | Drugs | Official Action Indicated (OAI) | 3004086192 |
| Aug 19, 2022 | Govandi, India | Drugs | Voluntary Action Indicated (VAI) | 3003255171 |
| Feb 7, 2020 | Takula Khed, Dist. Ratnagiri, India | Drugs | No Action Indicated (NAI) | 3002977798 |
| Aug 4, 2017 | Takula Khed, Dist. Ratnagiri, India | Drugs | Voluntary Action Indicated (VAI) | 3002977798 |
| Aug 2, 2017 | Dabhel, Daman, India | Drugs | Voluntary Action Indicated (VAI) | 3004086192 |
| Jun 10, 2016 | Dabhel, Daman, India | Drugs | Official Action Indicated (OAI) | 3004086192 |
| Oct 23, 2015 | Govandi, India | Drugs | Official Action Indicated (OAI) | 3003255171 |
| Aug 14, 2015 | Takula Khed, Dist. Ratnagiri, India | Drugs | Voluntary Action Indicated (VAI) | 3002977798 |
| Mar 27, 2015 | Dabhel, Daman, India | Drugs | Voluntary Action Indicated (VAI) | 3004086192 |
| Sep 6, 2013 | Dabhel, Daman, India | Drugs | Voluntary Action Indicated (VAI) | 3004086192 |
| Jun 11, 2013 | Govandi, India | Drugs | Official Action Indicated (OAI) | 3003255171 |
| Mar 8, 2013 | Takula Khed, Dist. Ratnagiri, India | Drugs | No Action Indicated (NAI) | 3002977798 |
| Oct 14, 2012 | Dabhel, Daman, India | Drugs | Voluntary Action Indicated (VAI) | 3004086192 |
| Dec 25, 2009 | Dabhel, Daman, India | Drugs | Voluntary Action Indicated (VAI) | 3004086192 |
| Dec 18, 2009 | Takula Khed, Dist. Ratnagiri, India | Drugs | Voluntary Action Indicated (VAI) | 3002977798 |
| Dec 9, 2009 | Govandi, India | Drugs | Voluntary Action Indicated (VAI) | 3003255171 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.