Drug factory · FDA FEI 3003706047
Cardinal Health 414, LLC
5030 First Avenue South, Ste 110, Seattle, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 13, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 0 with no problems, 6 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 |
|---|---|---|---|
| Jun 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 25, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 25, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 14, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2009 | 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.
Jun 13, 2025 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish written quality assurance procedures.
Feb 25, 2020 inspection
- Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not take appropriate corrective actions when necessary. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - 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.
Jan 25, 2018 inspection
- Personnel not qualified 21 CFR 212.10
Your personnel lack the training to perform their assigned functions. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not determine the need for an investigation and take appropriate corrective actions when necessary. - 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. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use and are not sufficiently specific.
Registered with FDA for: manufacture; positron emission tomography drug production.