Drug factory · FDA FEI 3006786767
Cardinal Health 414, LLC
131 Hartland Street, Ste B, E. Hartford, CT, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 1, 2025.
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 2011: 1 with no problems, 3 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 |
|---|---|---|---|
| Jul 1, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 8, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 13, 2011 | 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.
Jul 1, 2025 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. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. - Lab written procedures 21 CFR 212.60(f)
Laboratory written procedures are not established to ensure that the lab equipment is routinely maintained. - Correction of problems 21 CFR 212.71(c)
You did not take action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
Jun 18, 2019 inspection
- Supplies adequately controlled 21 CFR 212.60(d)
Your quality of supplies used in your testing procedures are not adequately controlled.
Registered with FDA for: manufacture; positron emission tomography drug production.