Drug factory · FDA FEI 2918710
AMPAC Fine Chemicals LLC
HIGHWAY 50 AND HAZEL AVENUE, Rancho Cordova, CA, United States
No problems found at FDA's last inspection, Sep 10, 2025.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2010: 2 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brigatinib | Makes the active ingredient and tests it | Takeda Pharmaceuticals America, Inc. | 63020-090, 63020-113, 63020-180 +1 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
| Elamipretide | Tests it | Stealth Biotherapeutics Inc. | 72507-800 |
| Finerenone | Makes the active ingredient | Bayer HealthCare Pharmaceuticals Inc. | 50419-540, 50419-541, 50419-542 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 10, 2025 | No problems found | Drug Quality Assurance | — |
| Jan 31, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 12, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 4, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 19, 2010 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.