FDA 483 - Hospira Zagreb d.o.o.

An FDA inspection of Hospira Zagreb d.o.o. in Prigorje Brdovečko, Croatia, revealed significant issues in their drug substance and drug product manufacturing facility. The firm experienced a critical malfunction during sterile drug product manufacturing, resulting in contamination and batch rejection. Additionally, written procedures for manufacturing and testing were found to be inadequate, particularly concerning outlier elimination in bioassays and the determination of equivalent chromatography columns.