Drug factory · FDA FEI 3010163919
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
No.99, 2nd Shendun Road, East Lake New Technology Development District, Wuhan, China
Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it | Epic Pharma, LLC | 42806-716 |
| Benzonatate | Makes it | Epic Pharma, LLC | 42806-714, 42806-715 |
| Calcitriol | Makes it | Epic Pharma, LLC | 42806-732, 42806-733 |
| Dutasteride | Makes it | Epic Pharma, LLC, Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., PuraCap Pharmaceutical LLC | 42806-549, 53345-037, 51013-190 |
| Ergocalciferol | Makes it | Epic Pharma, LLC | 42806-547 |
| Ethosuximide | Makes it | Epic Pharma, LLC | 42806-708, 42806-711 |
| Icosapent | Makes it | Epic Pharma, LLC | 42806-559, 42806-560, 42806-576 |
| Omega-3 Fatty Acids | Makes it | Epic Pharma, LLC | 42806-552 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| May 22, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.