FDA 483 - Sure-Tech Diagnostic Associates, Inc - July 29, 2026

Sure-Tech Diagnostic Associates, Inc. in Saint Louis, MO, was inspected by the FDA, revealing significant deficiencies in its quality management system documentation. The firm lacked documented procedures for risk management and supplier evaluation, and failed to establish a Medical Device File for its Fetal Hemoglobin Controls, indicating a broad failure to maintain required records and processes.