Drug factory · FDA FEI 3005574971

Syntese A/S

Industriholmen 13, Hvidovre, Denmark

Denmark: 1

Problems found, fixed voluntarily at FDA's last inspection, May 12, 2023.

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

3 drug inspections on record since 2014: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
MesalamineMakes the active ingredient and tests it Takeda Pharmaceuticals America, Inc. 54092-189, 54092-191

FDA inspection history

EndedResultProgramProblems noted
May 12, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 17, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 20, 2014Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label.