FDA 483 - Eclipse Technology Solutions Inc - May 01, 2024

An FDA inspection of Eclipse Technology Solutions Inc in Chadds Ford, PA, a human tissue establishment, revealed significant deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included failures to record and periodically review HCT/P storage temperatures. Additionally, the firm lacked documented procedures for determining the suitability of returned HCT/Ps for inventory.