FDA 483 - Novartis d.o.o. - February 09, 2024

An FDA inspection of Novartis d.o.o. in Ljubljana, Slovenia, identified three observations related to drug manufacturing practices. Deficiencies included inadequate routine calibration and checking of automatic equipment, insufficient visual examination of reserve drug product samples, and a lack of worst-case conditions in equipment dirty hold time studies. These observations indicate areas where the firm's quality systems require improvement to ensure proper performance and prevent contamination.