Community Blood Center – FDA 483, Jul 16, 2026
An FDA inspection of Community Blood Center dba Solvita in Dayton, OH, revealed two significant observations. The firm's clean room used for manufacturing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) was not maintained in a good state of repair, with multiple structural and environmental deficiencies posing a contamination risk. Additionally, the firm failed to report HCT/P deviations related to temperature excursions of skin grafts to the FDA within the required timeframe on two separate occasions.
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ID · dd6ff6c4-2244-461f-96ba-531692526d7c
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