Drug factory · FDA FEI 3006477751

Essential Isotopes, LLC

1513 Research Park Dr, Columbia, MO, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 11, 2026.

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

DrugRoleForNDC
Ammonia N-13Makes it Precision Nuclear LLC 52768-100
Fludeoxyglucose F-18Makes it Precision Nuclear LLC 52768-001
Flurpiridaz F-18Makes it GE Healthcare Inc. 0407-8787
Flutemetamol F-18Makes it Medi-Physics Inc. dba GE Healthcare. 17156-067
Piflufolastat F-18Makes it Progenics Pharmaceuticals, Inc. 71258-022

FDA inspection history

EndedResultProgramProblems noted
Sep 11, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 17, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 8, 2014No problems foundDrug Quality Assurance—
Aug 23, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: positron emission tomography drug production.