FDA 483 - Biotronik SE & Co. KG - June 23, 2022

An FDA inspection of Biotronik SE & Co. KG, a class III device manufacturer in Berlin, Germany, identified a significant issue regarding the documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately document these critical quality system processes. This indicates a deficiency in the firm's adherence to quality system requirements for medical device manufacturing.