Drug factory · FDA FEI 3002977798
USV Private Limited
B-1/8, MIDC, Lote Parshuram Industrial Area, Taluka Khed, Ratnagiri, India
Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Glyburide | Makes the active ingredient | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-056, 23155-057, 23155-058 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 7, 2020 | No problems found | Drug Quality Assurance | — |
| Aug 4, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 14, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 8, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 12, 2025 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; api manufacture; label; pack.