FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 16, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5b8989de-6d3a-451f-907b-7ccb9c53d1bf