Drug factory · FDA FEI 3008160514
Agilera Pharma AS
Instituttv 18, Kjeller, Norway
No problems found at FDA's last inspection, Mar 24, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Radium Ra-223 Cation | Makes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-208 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 24, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 1, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 19, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.