FDA 483 - Dualams, Inc. - November 10, 2025

Dualams, Inc., a Specification Developer and Complaint File Establishment in Irving, TX, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, ensure impartiality in internal audits, and properly evaluate critical suppliers. These observations indicate a need for improved adherence to established quality procedures.