Drug factory · FDA FEI 3006616345

Esteve Quimica, S.A.

Carretera Vendrell A Sant Jaume dels Domenys, KM 5, Banyeres del Penedes, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2025.

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

7 drug inspections on record since 2010: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
NeratinibMakes the active ingredient and tests it Puma Biotechnology, Inc. 70437-240

FDA inspection history

EndedResultProgramProblems noted
Oct 24, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 20, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 22, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 23, 2017No problems foundDrug Quality Assurance—
Apr 7, 2016No problems foundDrug Quality Assurance—
May 3, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 2, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.