FDA 483 - Spok, Inc. - July 19, 2024

During an inspection, Spok, Inc., a manufacturer in Alexandria, VA, was cited for significant deficiencies in its quality system. The firm failed to adequately establish, document, and implement critical procedures related to design controls, corrective and preventive actions, purchasing, and internal quality audits. These issues indicate a systemic breakdown in maintaining a compliant quality management system.