FDA 483 - Amnii-X LLC - February 20, 2018

GTR Medical Group, LLC, a human tissue storage/distributor in Plano, TX, was cited for two observations during an FDA inspection. The firm failed to perform and document corrective actions for out-of-range temperature excursions in its HCT/P storage room. Additionally, the inspection revealed that storage areas were not controlled to prevent mix-ups, specifically the co-mingling of expired and in-date HCT/Ps.