FDA 483 - Pfizer Ireland Pharmaceuticals Unlimited Company - January 26, 2018

An FDA inspection of Pfizer Ireland Pharmaceuticals Inc. in Ringaskiddy, County Cork, Ireland, revealed significant deficiencies in controls for preventing microbial contamination of non-sterile active pharmaceutical ingredients used in sterile drug products. The firm failed to establish adequate controls related to microbial identification during sampling, periodic challenging of equipment preparation effectiveness, and microbiological considerations for clean equipment holding times. These issues pose a risk of contaminating sterile products.