483
Boehringer Ingelheim RCV GmbH & Co KGFDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 19, 2018
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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.
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ID · e25819fd-f705-497d-90d5-9e3e164ead31