BioMed Diagnostocs, Inc – FDA 483, Mar 13, 2026

During an inspection, Diagnostic Consulting Network, LLC, a manufacturer of Research Use Only (RUO) products in Carlsbad, CA, was cited for significant deficiencies in its quality system. Observations included inadequate document control procedures, leading to obsolete RUO product information with clinical claims remaining on its website, and a lack of systematic review for marketing materials. Additionally, the firm failed to adequately maintain records of risk management activities, specifically regarding contradictory marketing claims for RUO products and the absence of risk assessments for their potential clinical misuse.