Drug factory · FDA FEI 3005909718
Eurofins PHAST GmbH
Kardinal-Wendel-Strasse 16, Homburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2009: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Canagliflozin and Metformin | Tests it | Janssen Pharmaceuticals, Inc. | 50458-940, 50458-941, 50458-942 +1 |
| Paliperidone | Tests it | Janssen Pharmaceuticals, Inc. | 50458-606, 50458-607, 50458-608 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 17, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2013 | No problems found | Drug Quality Assurance | — |
| May 27, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.