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 their quality control unit, process controls, and discrepancy investigations. Observations included a lack of quality unit oversight for critical manufacturing documentation and calibration records, absence of written procedures for assessing process alarms, and failure to thoroughly review unexplained discrepancies such as stability chamber excursions and deviation reports. These issues indicate a need for improved quality system implementation to ensure drug product quality and purity.