Drug factory · FDA FEI 3003613908
Cardinal Health, Inc.
7849 Almeda Road, Houston, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 21, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 3 with no problems, 1 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 |
|---|---|---|---|
| Feb 21, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 26, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 18, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 17, 2012 | 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.
Feb 21, 2026 inspection
- Record quality 21 CFR 212.110(b)
All records including those not stored at your inspected establishment are not stored to prevent deterioration or loss. - Equipment 21 CFR 212.60(e)
All equipment used to perform the testing is not suitable for its intended purposes and capable of producing valid results.
Registered with FDA for: manufacture; positron emission tomography drug production.