Drug factory · FDA FEI 3012304786
Cardinal Health 414, LLC
1405 Jefferson Hwy Ste B, New Orleans, LA, United States
No problems found at FDA's last inspection, May 22, 2026.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2018: 1 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 |
|---|---|---|---|
| May 22, 2026 | No problems found | Drug Quality Assurance | — |
| Aug 3, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 3, 2018 inspection
- Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned, suitable for its intended purposes and properly installed, maintained, and capable of repeatedly producing valid results that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
Registered with FDA for: manufacture; positron emission tomography drug production.