FDA 483 - Falck Medical Incorporated - August 21, 2023

During an inspection, Falck Medical Incorporated, a medical device manufacturer in Mystic, CT, was cited for multiple fundamental deficiencies in its quality system. The firm failed to establish written procedures for corrective and preventive actions, complaint handling, rework of nonconforming products, supplier management, incoming product acceptance, and equipment calibration. These observations indicate a significant lack of foundational quality system controls.