Drug factory · FDA FEI 3002808063
Bayer Aktiengesellschaft
Max-Dohrn-Str. 8, Berlin, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 16, 2023.
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 2011: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dienogest and Estradiol | Tests it and mills it | Bayer HealthCare Pharmaceuticals Inc. | 50419-409 |
| Drospirenone and Ethinyl Estradiol | Tests it and mills it | Bayer HealthCare Pharmaceuticals Inc. | 50419-402, 50419-405 |
| Drospirenone and Ethinyl Estradiol and Levomefolic Acid | Tests it and mills it | Bayer HealthCare Pharmaceuticals Inc., Sandoz Inc. | 50419-407, 0781-4075 |
| Finerenone | Packages it and mills it | Bayer HealthCare Pharmaceuticals Inc. | 50419-540, 50419-541, 50419-542 |
| Levonorgestrel | Tests it and mills it | Bayer HealthCare Pharmaceuticals Inc. | 50419-423, 50419-424 |
| Rivaroxaban | Tests it and mills it | Janssen Pharmaceuticals, Inc. | 50458-575 |
| Sevabertinib | Tests it and mills it | Bayer HealthCare Pharmaceuticals Inc. | 50419-397 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 2, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 14, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; pack; particle size reduction.