FDA 483 - Berlin Heart Inc - July 02, 2025

Berlin Heart Inc, a servicer of the EXCOR Pediatric Ventricular Assist Device (VAD), was inspected and received two observations. The inspection revealed inadequate procedures for servicing activities, including failures in documenting service reports, evaluating MDR reportability, and using statistical methodology. Additionally, the firm's quality system software, including Excel spreadsheets and fillable PDFs used for critical records, was not validated for its intended use, leading to issues with document control and data integrity.