Drug factory · FDA FEI 3002806906
Merck Kommanditgesellschaft auf Aktien
Frankfurter Str. 250, Darmstadt, Germany
Problems found, fixed voluntarily at FDA's last inspection, Oct 6, 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 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alcohol | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-999 |
| Praziquantel | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-747 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 6, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 27, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction; repack.