Berlin Heart Inc – FDA 483, Jul 2, 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.
- Office
- Dallas District Office
- Person
ID · 054b2d8f-c79e-47db-b5dd-6184f7820f55
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.