Drug factory · FDA FEI 3006400591
Biocon Limited
Plot No: 02, Road No: 21, Jawaharlal Nehru Pharma City, Thadi Village, IDA Paravada (M), Anakapalli, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 21, 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 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Everolimus | Makes the active ingredient | Biocon Pharma Inc. | 70377-069, 70377-070, 70377-071 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 2017 | No problems found | Drug Quality Assurance | — |
| May 30, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.