FDA 483 - Pfizer Ireland Pharmaceuticals Unlimited Company - November 12, 2019

An FDA inspection of Pfizer Ireland Pharmaceuticals in Clondalkin, Ireland, revealed two significant observations related to quality system deficiencies. The firm failed to submit required biological product deviation reports for confirmed US complaints of particles in Prevnar and did not thoroughly review unexplained discrepancies, including a test failure and incomplete BPDR information regarding an atypical rubber component in Prevnar. These issues highlight concerns with product quality and regulatory reporting.