Drug factory · FDA FEI 3011289655
Kashiv BioSciences, LLC
3440 S. Dearborn St, Suite 300, Chicago, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 14, 2024.
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 2015: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Filgrastim | Makes it and tests it | Amneal Pharmaceuticals LLC | 70121-1568, 70121-1569, 70121-1570 +1 |
| Pegfilgrastim | Makes it and tests it | Amneal Pharmaceuticals LLC | 70121-1627 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 26, 2018 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.