Drug factory · FDA FEI 3006234335

Cardinal Health 414, LLC

3845 Shopton Road, Ste 18A, 600B, Charlotte, NC, United States

United States: 1

No problems found at FDA's last inspection, Mar 26, 2026.

No Action Indicated: inspectors found no objectionable conditions.

7 drug inspections on record since 2010: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Flurpiridaz F-18Makes it GE Healthcare Inc. 0407-8787
Flutemetamol F-18Makes it Medi-Physics Inc. dba GE Healthcare. 17156-067

FDA inspection history

EndedResultProgramProblems noted
Mar 26, 2026No problems foundDrug Quality Assurance—
Oct 4, 2018No problems foundDrug Quality Assurance—
Apr 13, 2016No problems foundDrug Quality Assurance—
Sep 26, 2013No problems foundDrug Quality Assurance—
Feb 29, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 18, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
May 14, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

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