Drug factory · FDA FEI 3010419177
Optimus Drugs Private Limited
Unit - I, Survey No. 239 and 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri (D), India
Problems found, fixed voluntarily at FDA's last inspection, Dec 19, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aminocaproic Acid | Makes the active ingredient | Seton Pharmaceuticals, LLC | 13925-530, 13925-531 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 19, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 23, 2019 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.