FDA 483 - Collaborative Care Diagnostics, LLC dba BioMedix - October 18, 2021

An FDA inspection of Collaborative Care Diagnostics, LLC dba PCL-Medix in Eagan, MN, revealed two observations concerning inadequate design control procedures for their PADnet 4.0 system. The firm failed to adequately establish and implement procedures for design validation, with specific requirements not being tested. Additionally, procedures for design input were not adequately established, as the product requirement specifications lacked crucial system requirements.