FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 19, 2018

An FDA inspection of Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria, identified inadequate process equipment. Specifically, the firm's scraping practices introduced foreign particles into process intermediates, indicating a deficiency in maintaining equipment surfaces. This issue could compromise the quality of drug substances produced.