FDA 483 - CPM Medical Consultants, LLC. - August 29, 2025

An FDA inspection of CFM Medical Consultants, LLC. in Farmers Branch, TX, a medical device specification developer, revealed two significant observations. The firm failed to adequately validate a sterilization method for its medical device system, posing a risk of patient infection. Additionally, the firm did not submit a required Medical Device Report (MDR) for a complaint involving a device malfunction that led to a patient needing revision surgery.