FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - December 05, 2023

An FDA inspection of Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria, a manufacturer of drug substances, identified two significant observations. The firm's Standard Operating Procedures for critical shipping steps were found to be inadequate, lacking details on loading duration and container activation. Additionally, equipment preventive maintenance was deemed insufficient, resulting in frequent malfunctions and seal leaks on final container bottle head tubing for several drug substance batches.