Drug factory · FDA FEI 3003229486
Bayer AG
Friedrich-Ebert-Str. 217-333, Wuppertal, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jan 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ciprofloxacin | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-754, 50419-758, 50419-773 +1 |
| Finerenone | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-540, 50419-541, 50419-542 |
| Regorafenib | Makes the active ingredient, tests it and packages it | Bayer HealthCare Pharmaceuticals Inc. | 50419-171 |
| Rivaroxaban | Makes the active ingredient | Janssen Pharmaceuticals, Inc. | 50458-575 |
| Sevabertinib | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-397 |
| Sorafenib | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-488, 50419-489 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 29, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2015 | No problems found | Drug Quality Assurance | — |
| Dec 6, 2012 | No problems found | Drug Quality Assurance | — |
| May 27, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Feb 5, 2010 | No problems found | Drug Quality Assurance | — |
| May 26, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.