Boehringer Ingelheim Fremont, Inc. – FDA 483, Apr 4, 2017

This FDA Form 483 report identifies significant deficiencies at Boehringer Ingelheim Fremont, Inc., a facility manufacturing drug substances and products. The observations highlight inadequate validation procedures for sterile drug products, insufficient employee training for visual inspection, and issues with laboratory controls, equipment qualification, and quality assurance. These findings indicate a moderate to severe level of non-compliance, particularly impacting product sterility, quality control, and overall manufacturing integrity.