Drug factory · FDA FEI 3003846600
Cardinal Health 414, LLC
1224 3rd Avenue South, Birmingham, AL, United States
No problems found at FDA's last inspection, Mar 16, 2026.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2010: 2 with no problems, 2 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 16, 2026 | No problems found | Drug Quality Assurance | — |
| Feb 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jun 30, 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.
Apr 25, 2013 inspection
- Examine, approve or reject 21 CFR 212.20(b)
You did not approve or reject components in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not conduct an investigation when necessary. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure that all key process parameters are controlled. - Testing procedures 21 CFR 212.60(a)
Each laboratory used to conduct testing of finished PET drug products does not follow written procedures for the conduct of each test.
Registered with FDA for: manufacture; positron emission tomography drug production.