Drug factory · FDA FEI 3003663245

Inke Sa

Calle Argent (AREA INDUSTRIAL DEL LLOBREGAT) 1, Castellbisbal, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 15, 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: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
GranisetronMakes the active ingredient Heron Therapeutics, Inc. 47426-101

FDA inspection history

EndedResultProgramProblems noted
Mar 15, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 10, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 15, 2016No problems foundDrug Quality Assurance—
Jan 25, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 25, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.