FDA 483 - Medshift - December 13, 2024

An FDA inspection of Medshift, a specification developer in Charlotte, NC, from December 10-13, 2024, revealed ten significant deficiencies in its quality system. The firm failed to establish procedures for design control, process validation, supplier management, and training, and lacked essential records such as device history records and device master records. These findings indicate a broad lack of adequate controls for its Class II medical devices.