Drug factory · FDA FEI 3002808084
Bayer AG
Ernst-Schering-Str. 14, Bergkamen, Germany
Problems found, fixed voluntarily at FDA's last inspection, Nov 14, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Dienogest and Estradiol | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-409 |
| Drospirenone and Ethinyl Estradiol | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-402, 50419-405 |
| Drospirenone and Ethinyl Estradiol and Levomefolic Acid | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc., Sandoz Inc. |
50419-407, 0781-4075 |
| Finerenone | Tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-540, 50419-541, 50419-542 |
| Gadolinium Cation (3+) | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-325 |
| Gadoquatrane | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-321, 50419-322, 50419-323 +8 |
| Iopromide | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-342, 50419-344, 50419-346 |
| Levonorgestrel | Makes the active ingredient and tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-422, 50419-423, 50419-424 |
| Rivaroxaban | Tests it |
Janssen Pharmaceuticals, Inc. |
50458-575, 50458-577, 50458-578 +3 |
| Sevabertinib | Tests it |
Bayer HealthCare Pharmaceuticals Inc. |
50419-397 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Nov 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 10, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 12, 2015 | No problems found | Drug Quality Assurance | — |
| May 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 10, 2009 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.