Drug factory · FDA FEI 3004612405
Cardinal Health 414, LLC
7051 Muirkirk Meadows Drive, Ste L, Beltsville, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 9, 2024.
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: 3 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 |
|---|---|---|---|
| Jan 9, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 30, 2016 | No problems found | Drug Quality Assurance | — |
| Jan 17, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2009 | No problems found | Drug Quality Assurance | — |
| Jan 15, 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.
Jan 9, 2024 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Registered with FDA for: manufacture; positron emission tomography drug production.