FDA 483 - Forest Ambulatory Surgical Associates LLC - March 02, 2020

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.