Drug factory · FDA FEI 3003411150

Cardinal Health 414, LLC

795 Via Lata, Colton, CA, United States

No problems found at FDA's last inspection, Jun 26, 2025.

No Action Indicated: inspectors found no objectionable conditions.

6 drug inspections on record since 2010: 1 with no problems, 5 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

Ended	Result	Program	Problems noted
Jun 26, 2025	No problems found	Drug Quality Assurance	—
Apr 20, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
May 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 30, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 22, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 17, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.

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.
Laboratory Records Lack Required Data 21 CFR 212.60(g)(3)
Laboratory records did not contain properly identified graphs, charts, and spectra from laboratory instrumentation to show the specific drug product for each lot tested.
Statement of results and comparisons 21 CFR 212.60(g)(4)
Laboratory test records did not contain a statement how the results compare with established acceptance criteria.

Registered with FDA for: manufacture; positron emission tomography drug production.