483
Forest Ambulatory Surgical Associates LLCForest Ambulatory Surgical Associates LLC – FDA 483, Mar 2, 2020
Record Details
An FDA inspection of Forest Ambulatory Surgical Associates, LLC in San Jose, CA, a human tissue establishment, revealed significant deficiencies in their handling and storage of Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps). Observations included failures to document transfer temperatures, maintain appropriate shipping conditions with expired materials, perform routine equipment calibration, and conduct periodic reviews of recorded temperatures.
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ID · 55f30b86-a86e-4070-bed9-b9fad84db6f1
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