FDA 483 - PharOs MT Ltd. - February 06, 2017

Arrow Pharm (Malta) Ltd., a human drug manufacturer in Birzebbugia, Malta, was cited for two significant issues during an FDA inspection. The firm's stability program for drug products lacked statistical criteria for test intervals, and a substantial portion of lots were placed in stability well after distribution. Additionally, the validation of manual cleaning procedures for non-dedicated manufacturing equipment was found inadequate, specifically lacking required recovery studies for medium-risk contact surfaces.