FDA 483 - Charlotte Mecklenburg Hospital Authority dba Lifeshare Carolinas - May 18, 2023

Charlotte Mecklenburg Hospital Authority dba LifeShare Carolinas received a Form 483 for deficiencies in its HCT/P manufacturing operations. The inspection revealed failures in environmental monitoring within the laminar flow hood, lack of demonstrated efficacy for disinfectants, and absence of written procedures for environmental monitoring. These issues indicate a lack of adequate controls to prevent contamination of human cells, tissues, and cellular and tissue-based products.