PLIVA Hrvatska d.o.o. – FDA 483

An FDA inspection of Pliva Croatia Ltd. c/o Teva Pharmaceuticals, USA in Horsham, PA, from May 29-31, 2018, identified two observations. The inspection focused on the firm's analytical facility and particle size distribution data. The observations primarily concerned the lack of demonstrated stability for a test product during dialysis and prior to DLS analysis, as well as insufficient documentation of storage conditions.