Drug factory · FDA FEI 3002806964

Farmhispania S.A.

Passeig Riu Besos, 9-10, Montmelo, Spain

Spain: 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.

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

What it does, for whom

DrugRoleForNDC
Canagliflozin and MetforminMakes the active ingredient and tests it Janssen Pharmaceuticals, Inc. 50458-540, 50458-541, 50458-542 +5
Metformin and PioglitazoneMakes the active ingredient Takeda Pharmaceuticals America, Inc. 64764-158

FDA inspection history

EndedResultProgramProblems noted
May 12, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 16, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 15, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 12, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 29, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.