Drug factory · FDA FEI 3010166650
Cardinal Health 414, LLC
4376 Alexander Boulevard NE, Albuquerque, NM, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2014: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flutemetamol F-18 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 17, 2014 | No problems found | 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.
Sep 25, 2024 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Stability testing program 21 CFR 212.61(a)
You did not follow a written testing program to assess the stability characteristics of your PET drug products.
Registered with FDA for: manufacture; positron emission tomography drug production.