Drug factory · FDA FEI 3011248248
Biocon Sdn.bhd.
No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, Iskander Puteri, Malaysia
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Insulin Aspart | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-007, 83257-008 |
| Insulin Glargine | Makes it, tests it and packages it | Biocon Biologics Inc., Civica, Inc. | 83257-011, 83257-012, 72572-422 +1 |
| Water | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-006 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.