FDA 483 - Boehringer Ingelheim Fremont, Inc. - November 04, 2022

An FDA inspection of Boehringer Ingelheim Fremont, Inc. from October 25 to November 4, 2022, revealed significant deficiencies in the firm's quality control unit. The inspection found that procedures for logbook review and deviation documentation were not adequately written or followed. Additionally, process description documents contained non-quantitative statements allowing for undocumented transient excursions from operating parameters.