FDA 483 - Collaborative Care Diagnostics, LLC dba BioMedix - February 09, 2026

An FDA inspection of Collaborative Care Diagnostics, LLC. in Eagan, MN, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately document risk management processes, evaluate design changes, and ensure proper Unique Device Identifier (UDI) labeling and database submission for their PADnet 4.0 and PADnet Xpress products. These observations indicate a lack of robust controls over product realization and regulatory compliance.