Drug factory · FDA FEI 1910565

Roquette America, Inc.

1003 South 5th St., Keokuk, IA, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 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 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Anhydrous DextroseMakes the active ingredient Hospira, Inc. 0409-1775

FDA inspection history

EndedResultProgramProblems noted
Jan 30, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 17, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 3, 2016No problems foundDrug Quality Assurance—
Mar 7, 2012No problems foundDrug Quality Assurance—
Apr 1, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.