FDA 483 - Pfizer Manufacturing Belgium NV - June 08, 2023

An FDA inspection of Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Belgium, identified one observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, investigations into injector pen device complaints, such as blockages and underfills, lacked sufficient documentation. This indicates a deficiency in the firm's quality system regarding CAPA record-keeping.