FDA 483 - Boehringer Ingelheim Biopharmaceuticals (China) Ltd. - June 09, 2023

An FDA inspection of Boehringer Ingelheim BioPharmaceuticals (China) Ltd. in Shanghai revealed significant deficiencies across multiple areas of drug substance and drug product manufacturing. Observations included failures in quality unit procedures, visual inspection processes, aseptic manufacturing controls, and data integrity. These issues indicate a lack of adherence to established protocols and inadequate controls, posing potential risks to product quality and sterility.