Drug factory · FDA FEI 3009710633
Cardinal Health, Inc.
1950 Bentley Ct, Glendale Heights, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 15, 2025.
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
| Drug | Role | For | NDC |
|---|---|---|---|
| Flurpiridaz F-18 | Makes it | GE Healthcare Inc. | 0407-8787 |
| Flutemetamol F-18 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 15, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 16, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 14, 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.
Aug 15, 2025 inspection
- Master Production and Control Records 21 CFR 212.50(b)
You did not have master production and control records that document all steps in the PET drug production process. - Lab sampling and test procedures 21 CFR 212.60(b)
Each laboratory did not have testing procedures which are designed to ensure that PET drug products conform to appropriate standards including established standards of identity, strength, quality and purity.
Registered with FDA for: manufacture; positron emission tomography drug production.