483
Eclipse Technology Solutions IncEclipse Technology Solutions Inc – FDA 483, May 1, 2024
Record Details
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.
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ID · 5980f72a-c639-4d6a-89eb-f81f01066fa4
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