Drug factory · FDA FEI 3006563584
Jubilant DraxImage Inc., dba Jubilant Radiopharma
825 Executive Park Drive, Mobile, AL, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 23, 2026.
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: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 23, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 13, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 23, 2026 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Contact surfaces 21 CFR 212.30(c)
Your equipment is not constructed so that surfaces that contact components, in-process materials and PET drugs are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
Registered with FDA for: positron emission tomography drug production.