FDA 483 - Pfizer Manufacturing Deutschland GmbH - February 03, 2020

An FDA inspection of Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau, Germany, revealed significant deficiencies in the firm's quality control unit, written procedures for production and process controls, and discrepancy investigations. The observations highlight a lack of adequate oversight and control over critical manufacturing processes and product quality. These issues indicate a need for comprehensive improvements in the firm's quality management system for drug product manufacturing.