Drug factory · FDA FEI 3009930596
Washington University, The
510 S. Kingshighway Blvd, Saint Louis, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | Washington University School of Medicine | 75913-113 |
| Fludeoxyglucose F-18 | Makes it | Washington University School of Medicine | 75913-647 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: positron emission tomography drug production.