FDA 483 - Boehringer Ingelheim Fremont - May 16, 2024

The FDA inspected Boehringer Ingelheim Fremont, a drug substance manufacturer, from May 8-16, 2024. The inspection revealed significant deficiencies across quality unit procedures, equipment control and qualification, facility maintenance, contamination prevention, manufacturing process validation, laboratory procedures, and adherence to BLA parameters. These issues indicate a broad lack of control over critical aspects of drug substance manufacturing, posing a moderate to severe risk to product quality and patient safety.