The U.S. Food and Drug Administration (FDA) at PLIVA
In February 2015, PLIVA HRVATSKA, a member of the Teva Group, was inspected by the United States Food and Drug Administration (FDA).
The FDA inspectors reviewed processes and procedures at PLIVA’s production site in Zagreb in order to establish whether products manufactured at the site comply with Good Manufacturing Practice (GMP). This year's inspection covered the production of active pharmaceutical ingredients, oral solid forms, semi solids and sterile drug products. It was completed in the beginning of February and FDA inspectors found no observations.
As FDA’s main objective is to protect human health, it is known for its rigorous regulatory requirements and control of the production of active pharmaceutical ingredients and drug products for the U.S. market. PLIVA is the only FDA-approved manufacturer of active pharmaceutical ingredients and finished dosage forms in Croatia, and it has been regularly audited by FDA since 1965. The inspected facilities supply products for Croatian, US and other pharmaceutical markets.
“PLIVA’s production processes are regularly audited by foreign regulatory agencies and by the Croatian Agency for Medicinal Products and Medical Devices. This inspection has again confirmed PLIVA’s compliance with GMP and other standards relevant for the pharmaceutical industry “, emphasized Zoran Bunčić, Head of Operations Croatia and member of PLIVA’s Management Board. ”Quality is our top priority and our people are investing continuous efforts to bring all of our operations in compliance with the highest quality standards in the interest of our patients worldwide”, added Romana Šantar, Head of TAPI Croatia and member of PLIVA’s Management Board.