Drug factory · FDA FEI 3004837462

Synthon Hispania S.L.

Calle Castello, 1 - PG Salinas, Sant Boi de Llobregat, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 20, 2023.

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 2010: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
EltrombopagMakes it, tests it, packages it and labels it Amerisyn, LLC, Somerset Therapeutics, LLC 87564-032, 87564-033, 87564-034 +5
PomalidomideMakes it Caraco Pharmaceutical Laboratories, Ltd. 70095-057, 70095-058, 70095-059 +1
TamsulosinMakes it, tests it, packages it and labels it Exelan Pharmaceuticals, Inc. 76282-744

FDA inspection history

EndedResultProgramProblems noted
Apr 20, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 28, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 23, 2014No problems foundDrug Quality Assurance—
Oct 1, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

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