FDA 483 - BERLIN HEART GMBH - October 13, 2022

The FDA conducted an inspection of Berlin Heart GmbH, a medical device manufacturer located in Berlin, Germany, from October 10 to October 13, 2022. The inspection revealed several critical compliance issues related to the company's quality management systems, specifically in their corrective and preventive actions (CAPA), medical device reporting (MDR), and design controls.

Key violations included the inadequate implementation of procedures for corrective and preventive actions. The company failed to fully investigate quality problems with their EXCOR Pediatric Ventricular Assist Device (VAD), such as defects in the blood pump membrane and unresponsiveness issues, as documented under CAPA Nos. CP-13-002 and CP-18-024. Additionally, the company did not ensure proper supplier qualification and quality agreements.

The inspection also identified deficiencies in the MDR procedures, which lacked a standardized process for evaluating events to determine if they require reporting to the FDA. The current procedure did not adequately define how evaluations should be conducted, relying instead on the discretion of the Person Responsible for Regulatory Compliance (PRRC).

Furthermore, the company's design control procedures were found lacking. Specifically, there were unresolved issues with incomplete or ambiguous design requirements for the EXCOR Pediatric VAD, and the design output procedures were not fully implemented.

The FDA requires Berlin Heart GmbH to address these issues by establishing and implementing comprehensive corrective actions to ensure compliance with quality system regulations. The company is responsible for conducting internal audits to identify and rectify all violations.