FDA 483 - Berlin Heart Inc - July 02, 2025

During an inspection conducted from June 25 to July 2, 2025, the FDA issued a Form 483 to Berlin Heart Inc., a medical device servicer located in The Woodlands, TX. The inspection highlighted two primary concerns related to the company's quality system practices for the life-sustaining EXCOR Pediatric Ventricular Assist Device (VAD).Firstly, Berlin Heart Inc. lacked adequately established procedures for servicing activities. The firm's service log, an Excel spreadsheet, failed to ensure that repaired devices consistently met design specifications. Specific deficiencies included the absence of statistical analysis for service reports, a failure to automatically classify reportable events (mandated by 21 CFR 803) as complaints, and insufficient documentation of critical service details such as Unique Device Identifiers (UDI) and assessments for Medical Device Report (MDR) reportability.Secondly, software applications, specifically Excel spreadsheets and fillable PDFs used for managing vital quality system records (e.g., routine maintenance, complaints, nonconformances), had not been validated for their intended use. This oversight compromised the accuracy and reliability of the data. Furthermore, document control practices were inadequate, permitting changes or deletions to electronic records without tracking modifications, dates, or the individuals responsible, thereby undermining data integrity.Berlin Heart Inc. acknowledged these observations and committed to implementing corrective actions to address the identified deviations, bringing their operations into compliance with FDA's Quality System Regulation.