FDA 483 - MindSight Medical LLC - May 05, 2025

MindSight Medical LLC in Dallas, TX, a human tissue distributor, was cited for two observations during an FDA inspection. The firm failed to establish acceptable temperature limits for storing HCT/Ps according to manufacturer specifications and lacked defined temperature ranges for frozen HCT/Ps. Additionally, the firm's Standard Operating Procedures did not define corrective actions for temperature excursions during HCT/P storage.