Drug factory · FDA FEI 3010630287

Hospira Zagreb d.o.o.

Prudnicka cesta 60, Prigorje Brdovecko, Croatia

Croatia: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 23, 2024.

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 2018: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
FilgrastimMakes it, makes the active ingredient, tests it, packages it and labels it Pfizer Laboratories Div Pfizer Inc 0069-0291, 0069-0292, 0069-0293 +1
PegfilgrastimMakes it, makes the active ingredient, tests it, packages it and labels it Pfizer Laboratories Div Pfizer Inc 0069-0324

FDA inspection history

EndedResultProgramProblems noted
Jul 23, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 16, 2021No problems foundDrug Quality Assurance—
Mar 22, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 20, 2018Problems found, fixed voluntarilyDrug Quality Assurance—

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