Drug factory · FDA FEI 3008212446
Cardinal Health 414, LLC
10400 E. 48th Avenue, Suite A, Denver, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 24, 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 2012: 1 with no problems, 2 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 24, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 17, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 19, 2012 | 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.
Sep 24, 2024 inspection
- Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Registered with FDA for: manufacture; positron emission tomography drug production.