FDA 483 - SIM Med, LLC - April 10, 2025

An FDA inspection of SIM MED, LLC in Sussex, WI, revealed significant deficiencies across multiple quality system areas. The firm lacked proper procedures for Medical Device Reporting (MDR), failed to validate critical manufacturing processes for its Q-Collar device, and did not adequately control process parameters or document CAPA activities. Additionally, supplier management and evaluation records were found to be insufficient.