FDA 483 - Swiss Bionic Solutions GmbH - September 28, 2023

An FDA inspection of Swiss Bionic Solutions GmbH in Schindellegi, Switzerland, revealed multiple significant deficiencies in their quality system. The firm failed to establish or adequately implement critical procedures for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), finished device acceptance, and design changes. Additionally, essential documents like the Design History File and Device Master Record were not properly approved.