FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 16, 2023

An FDA inspection of Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria, a drug substance manufacturer, revealed significant issues primarily related to contamination control and quality system deficiencies. The firm experienced repeated contamination events in drug substance and intermediate batches, indicating inadequate manufacturing controls. Further concerns included incomplete master production records, insufficient investigations and CAPA initiation, poor laboratory controls, inadequate analytical SOPs, and improper cleanroom qualification and material storage practices.