Consumer Product Partners, LLC – FDA 483, Oct 13, 2021

Vi-Jon, Inc. in St. Louis, MO, a drug manufacturer, was inspected and cited for significant quality system deficiencies. Observations included failures in following written procedures for component handling and water system management, inadequate controls to prevent objectionable microorganisms, and poor data integrity practices. The firm also demonstrated a lack of thorough investigation into discrepancies and had deficient complaint handling processes, indicating systemic issues in their quality unit oversight.