Drug factory · FDA FEI 3002807920

Zaklady Farmaceutyczne Polpharma S A

Ul. Pelplinska 19, Starogard Gdanski, Poland

Poland: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 2025.

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: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Alendronic AcidMakes the active ingredient Radius Health, Inc. 70539-400

FDA inspection history

EndedResultProgramProblems noted
Oct 17, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
May 25, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 29, 2015No problems foundDrug Quality Assurance—
Sep 20, 2012No problems foundDrug Quality Assurance—
Jan 29, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.