Drug factory · FDA FEI 3004972463
Cardinal Health 414, LLC
110 Science Pkwy, Ste 200, Rochester, NY, United States
No problems found at FDA's last inspection, Aug 29, 2025.
No Action Indicated: inspectors found no objectionable conditions.
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 |
|---|---|---|---|
| Flutemetamol F-18 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 1, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 5, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture; positron emission tomography drug production.