Drug factory · FDA FEI 3002807965

Quimica Sintetica Sa

CALLE DULCINEA, S/N, Alcala De Henares, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2025.

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

6 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
GuanfacineMakes the active ingredient Takeda Pharmaceuticals America, Inc. 54092-513, 54092-515, 54092-517 +1

FDA inspection history

EndedResultProgramProblems noted
Apr 23, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 6, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 22, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 9, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 31, 2013No problems foundDrug Quality Assurance—
Jul 8, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.