PharOs MT Ltd. – FDA 483, Feb 6, 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.
ID · cce732b7-4813-4853-9edd-46bd837ae850
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