Drug factory · FDA FEI 1419579

SpecGx LLC

100 Louis Latzer Dr., Greenville, IL, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 27, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Acetaminophen and CodeineMakes the active ingredient SpecGx LLC 0406-0483, 0406-0484, 0406-0485
Acetaminophen and HydrocodoneMakes the active ingredient Golden State Medical Supply, Inc., SpecGx LLC 60429-590, 60429-591, 60429-592 +6
Acetaminophen and OxycodoneMakes the active ingredient SpecGx LLC 0406-0512, 0406-0522, 0406-0523

FDA inspection history

EndedResultProgramProblems noted
Feb 27, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 25, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 7, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 5, 2012No problems foundDrug Quality Assurance—
Feb 20, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.