Drug factory · FDA FEI 3008297570

SOFIE Co. dba SOFIE

801 Forestwood Drive, Romeoville, IL, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 12, 2024.

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: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Florbetaben F-18Makes it Lantheus Biosciences Ltd., a Lantheus company 54828-001
Fludeoxyglucose F-18Makes it SOFIE Co. dba SOFIE 49609-101
Fluoride Ion F-18Makes it SOFIE Co. dba SOFIE 49609-102
Flurpiridaz F-18Makes it GE Healthcare Inc. 0407-8787
Piflufolastat F-18Makes it Progenics Pharmaceuticals, Inc. 71258-022

FDA inspection history

EndedResultProgramProblems noted
Jul 12, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 30, 2015No problems foundDrug Quality Assurance—
Aug 15, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 28, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: positron emission tomography drug production.