Drug factory · FDA FEI 3006129086
Genentech, Inc.
1 Antibody Way, Oceanside, CA, United States
No problems found at FDA's last inspection, Aug 16, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Alteplase | Tests it |
Genentech, Inc. |
50242-041, 50242-044, 50242-085 |
| Atezolizumab | Tests it |
Genentech, Inc. |
50242-917, 50242-918 |
| Atezolizumab and Hyaluronidase (human Recombinant) | Tests it |
Genentech, Inc. |
50242-933 |
| Bevacizumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-060, 50242-061 |
| Crovalimab | Tests it |
Genentech, Inc. |
50242-115 |
| Dornase Alfa | Tests it |
Genentech, Inc. |
50242-100 |
| Faricimab | Tests it |
Genentech, Inc. |
50242-096 |
| Glofitamab | 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 | Tests it |
Genentech, Inc. |
50242-077 |
| Mosunetuzumab | Tests it |
Genentech, Inc. |
50242-142, 50242-159, 50242-177 +1 |
| Obinutuzumab | Tests it |
Genentech, Inc. |
50242-070 |
| Ocrelizumab | Tests it |
Genentech, Inc. |
50242-150 |
| Omalizumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-040, 50242-214, 50242-215 +1 |
| Pertuzumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-145 |
| Polatuzumab Vedotin | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-103, 50242-105 |
| Rituximab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-051, 50242-053 |
| Tenecteplase | Tests it |
Genentech, Inc. |
50242-014, 50242-120, 50242-176 |
| Tocilizumab | Makes the active ingredient and tests it |
Genentech, Inc. |
50242-135, 50242-136, 50242-137 +2 |
| Trastuzumab | Tests it |
Genentech, Inc. |
50242-132 |
| Trastuzumab Emtansine | Tests it |
Genentech, Inc. |
50242-087, 50242-088 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Aug 16, 2024 | No problems found | Drug Quality Assurance | — |
| Oct 18, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 23, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.