Drug factory · FDA FEI 3007934434
Partner Therapeutics, Inc.
2625 162nd Street SW, Lynnwood, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 22, 2022.
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 2009: 0 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Sargramostim | Makes the active ingredient and tests it | Partner Therapeutics, Inc. | 71837-5843 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 18, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.