Drug factory · FDA FEI 3002806560
Roche Diagnostics GmbH
Nonnenwald 2, Penzberg, Germany
Problems found, fixed voluntarily at FDA's last inspection, May 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Atezolizumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-917, 50242-918 |
| Atezolizumab and Hyaluronidase (human Recombinant) | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-933 |
| Bevacizumab | Tests it |
Genentech, Inc. |
50242-060, 50242-061 |
| Crovalimab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-115 |
| Dornase Alfa | Tests it |
Genentech, Inc. |
50242-100 |
| Emicizumab | Tests it |
Genentech, Inc. |
50242-920, 50242-921, 50242-922 +3 |
| Faricimab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-096 |
| Glofitamab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-125, 50242-127 |
| Hyaluronidase (human Recombinant) and Ocrelizumab | Tests it |
Genentech, Inc. |
50242-554 |
| Hyaluronidase (human Recombinant) and Pertuzumab and Trastuzumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-245, 50242-260 |
| Hyaluronidase (human Recombinant) and Rituximab | Tests it |
Genentech, Inc. |
50242-108, 50242-109 |
| Hyaluronidase (human Recombinant) and Trastuzumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-077 |
| Methoxy Polyethylene Glycol-Epoetin Beta | Makes the active ingredient |
Vifor (International) Inc. |
59353-400, 59353-401, 59353-402 +6 |
| Mosunetuzumab | Tests it |
Genentech, Inc. |
50242-142, 50242-159, 50242-177 +1 |
| Obinutuzumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-070 |
| Ocrelizumab | Tests it |
Genentech, Inc. |
50242-150 |
| Pertuzumab | Tests it |
Genentech, Inc. |
50242-145 |
| Polatuzumab Vedotin | Tests it |
Genentech, Inc. |
50242-103, 50242-105 |
| Rituximab | Tests it |
Genentech, Inc. |
50242-051, 50242-053 |
| Tocilizumab | Tests it |
Genentech, Inc. |
50242-135, 50242-136, 50242-137 +2 |
| Trastuzumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-132 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| May 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 16, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 25, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.