Drug factory · FDA FEI 3004005970
BWXT Medical Ltd.
4004 Wesbrook Mall, Vancouver, Canada
Problems found, fixed voluntarily at FDA's last inspection, Feb 23, 2024.
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 2010: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rubidium Cation Rb-82 | Makes the active ingredient | Bracco Diagnostics Inc. | 0270-0091 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 23, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 11, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.