Drug factory · FDA FEI 3004437307
Rafa Laboratories Ltd.
3 Zeev Lev, Jerusalem, Israel
Problems found, fixed voluntarily at FDA's last inspection, Nov 25, 2019.
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 2016: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atropine | Makes it | Rafa Laboratories, Ltd. | 71053-590, 71053-591, 71053-592 |
| Midazolam | Makes it | Rafa Laboratories, Ltd. | 71053-595 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture.