FDA 483 - Pfizer Manufacturing Belgium NV - May 17, 2024

An FDA inspection of Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Belgium, revealed significant deficiencies in sterile drug product manufacturing processes, including inadequate sterilization of equipment contact surfaces and environmental monitoring. The inspection also cited failures in following standard operating procedures for endotoxin testing and documentation practices, as well as poor maintenance of critical manufacturing utilities and equipment. These issues raise concerns regarding product quality and sterility assurance.