Drug factory · FDA FEI 3001027806
Gilead Alberta ULC
1021 Hayter Rd NW, Edmonton, Canada
No problems found at FDA's last inspection, May 12, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 6 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cobicistat and Darunavir | Makes the active ingredient | Janssen Products LP | 59676-575 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 12, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 5, 2011 | No problems found | Drug Quality Assurance | — |
| Mar 26, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.