Drug factory · FDA FEI 3004771217
Cardinal Health, Inc.
5795 Arville St Ste 100, Las Vegas, NV, United States
No problems found at FDA's last inspection, Mar 12, 2026.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 3 with no problems, 3 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 |
|---|---|---|---|
| Mar 12, 2026 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 3, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 7, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2010 | 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.
Mar 18, 2021 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.