Drug factory · FDA FEI 3009592290
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka, Paiania, Greece
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.
5 drug inspections on record since 2018: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brimonidine and Timolol | Makes it | Upsher-Smith Laboratories, Inc. | 0832-1425 |
| Difluprednate | Makes it | Upsher-Smith Laboratories, Inc. | 0832-6054 |
| Norepinephrine | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-983 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 19, 2023 | No problems found | Bioresearch Monitoring | — |
| Jun 4, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 11, 2020 | No problems found | Bioresearch Monitoring | — |
| May 31, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.