Drug factory · FDA FEI 3007112035
Cardinal Health 414, LLC
3016 USF Hawthorn Drive, Tampa, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 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 2013: 0 with no problems, 4 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 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 8, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 12, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 19, 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.
Feb 6, 2026 inspection
- Complaint record contents 21 CFR 212.100(c)
Your written complaint record does not include the nature of the complaint and the response to the complaint. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Non-Conforming Product Investigation Incomplete 21 CFR 212.71(a)
The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the other relevant sources of information concerning the nonconforming product. - Correction of problems 21 CFR 212.71(c)
You did not take appropriate action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
Nov 8, 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.
Nov 12, 2015 inspection
- Conform to specs prior to release 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release.
Registered with FDA for: manufacture; positron emission tomography drug production.