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

During an FDA inspection conducted from January 22-26, 2018, Pfizer Ireland Pharmaceuticals Inc. in Ringaskiddy, County Cork, Ireland, received a Form 483 for significant observations. The primary issue identified was the firm's failure to establish adequate controls to prevent non-sterile active pharmaceutical ingredients (APIs), intended for use in sterile drug products, from containing microorganisms. Specific violations included deficiencies in their microbial testing procedures, where microorganisms below a certain colony count threshold were not identified, potentially allowing objectionable contaminants to go undetected. Additionally, the effectiveness of the equipment preparation procedure, designed to prevent microbial contamination, had not been periodically re-evaluated or challenged since its establishment in 2009. The inspection also noted a lack of microbiological studies to support the established clean equipment holding times for unsealed equipment, raising concerns about potential microbial growth during storage. These observations indicate deviations from current good manufacturing practices. Pfizer Ireland Pharmaceuticals Inc. is required to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure the sterility and quality of its pharmaceutical products.