FDA 483 - MindSight Medical LLC - February 22, 2019

Mindsight Medical LLC, a human tissue distributor in Dallas, TX, was cited for significant deficiencies during an FDA inspection. The firm failed to establish, maintain, and follow appropriate procedures for HCT/Ps, specifically regarding temperature limits for ambient storage and the completion of various operational forms. Additionally, the firm failed to perform and document corrective actions for temperature excursions in an ultra low freezer used for HCT/P storage.