FDA 483 - KDC/ONE SOCAL LABORATORIES, LLC - September 13, 2022

KDC/ONE SOCAL LABORATORIES, LLC in Walnut, CA, was inspected and cited for significant deficiencies across its quality system, laboratory system, and facilities and equipment. The inspection revealed failures in quality control procedures, inadequate complaint handling, insufficient computer system controls, and a complete lack of equipment cleaning records. These issues indicate a systemic breakdown in maintaining proper manufacturing and control standards for drug products.