# FDA 483 - BERLIN HEART GMBH - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/berlin-heart-gmbh/3693453e-89d7-4fcf-a05a-8ef8f5834d22

> FDA 483 for BERLIN HEART GMBH on October 13, 2022. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BERLIN HEART GMBH
- Inspection Date: 2022-10-13
- Product Type: Devices
- Office Name: Office of Inspections and Investigations
- Summary: 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 significant compliance issues related to the company's quality management systems, specifically in their corrective and preventive actions (CAPA), medical device reporting (MDR), and design control procedures.

Key violations include 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 component and issues with unresponsive devices. These investigations did not determine the root causes or address supplier qualification and quality agreements effectively.

Additionally, the firm's MDR procedures lacked a standardized review process for determining reportable events, potentially leading to inconsistent evaluations. The design control procedures were also found lacking, with incomplete mechanisms for resolving ambiguous design requirements and inadequate documentation of design outputs.

The FDA requires Berlin Heart GmbH to address these deficiencies by establishing and implementing comprehensive corrective actions. This includes revising CAPA procedures to ensure thorough investigations, standardizing MDR evaluation processes, and enhancing design control procedures to resolve incomplete or conflicting design requirements. The company is expected to conduct internal audits to identify and rectify all quality system violations, ensuring compliance with FDA regulations.

## Related Documents

- [483 - 2022-10-13](https://www.globalkeysolutions.net/records/483/berlin-heart-gmbh/2c52abc5-ddfb-4697-9b42-cb71ef817d72)

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/berlin-heart-gmbh/91a114a5-6d49-4328-95a6-cb5d05a4bdeb

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8