FDA 483 - KDC/ONE SOCAL LABORATORIES, LLC - April 14, 2026

KDC/ONE SOCAL LABORATORIES, LLC in Walnut, CA, a contract manufacturer, was cited for significant deficiencies in its quality control, stability testing, and equipment cleaning practices during an FDA inspection. Observations included inadequate testing of raw materials, failure to conduct ongoing stability studies and annual reserve sample examinations, and poor documentation and execution of equipment cleaning. A mixing tank marked as "cleaned" was found with visible residue, indicating a lack of control over critical manufacturing processes for OTC drug products.