FDA 483 - Pfizer Healthcare India Private Limited - October 18, 2022

An FDA inspection of Pfizer Healthcare India Private Limited in Visakhapatnam, India, a sterile drug manufacturer, revealed significant deficiencies in equipment design, qualification, and maintenance. These issues led to particle contamination in drug products, resulting in multiple recalls and Field Alert Reports, and the presence of rust in manufacturing vessels. The firm failed to adequately qualify cleaning equipment and implement proper preventative maintenance actions.