Eclipse Technology Solutions IncMay 1, 2024

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

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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.

Company: Eclipse Technology Solutions Inc
Inspection Date: May 1, 2024
Product Type: Biologics
Office: Philadelphia District Office
Person: Kish Bolden

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ID · 5980f72a-c639-4d6a-89eb-f81f01066fa4