Drug factory · FDA FEI 3005804912
Eurofins CDMO Alphora Inc
2884 Portland Dr, Oakville, Canada
Problems found, fixed voluntarily at FDA's last inspection, Jan 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Avapritinib | Makes the active ingredient and tests it | Blueprint Medicines Corporation | 72064-110, 72064-120, 72064-125 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 29, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 20, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.