Boehringer Ingelheim RCV GmbH & Co KG – FDA 483, Dec 5, 2023

During an inspection conducted from November 29 to December 5, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria. The observations relate to conditions and practices that potentially impact product quality and safety, falling under the regulatory purview of the Federal Food, Drug, and Cosmetic Act. The inspection identified two primary issues. Firstly, a Standard Operating Procedure (SOP) for critical shipping steps was deemed inadequate. Specifically, the procedure for packing drug substance final containers lacked clear instructions regarding the duration for loading containers into specific equipment and how to activate certain RCV equipment. Secondly, the facility's equipment preventive maintenance was found to be insufficient, contributing to frequent malfunctions. This was evidenced by seal leaks observed on the final container bottle head tubing for three different drug substance batches after the sealing process. These observations require Boehringer Ingelheim RCV GmbH & Co KG to promptly investigate and implement corrective actions to ensure proper controls are in place and prevent recurrence. The company is expected to provide a detailed response addressing how these issues will be rectified to meet regulatory expectations.