FDA 483 - Edge Biologicals Inc - April 04, 2023

Edge Biologicals Inc in Memphis, TN, was inspected and received a Form FDA-483 with eight observations, many of which were repeat findings from previous inspections. The inspection revealed significant deficiencies in quality system procedures, including validation of aseptic processes, corrective and preventive actions, supplier quality, environmental monitoring, and employee training. These issues indicate a systemic lack of control over manufacturing processes for culture media devices and suggest a high risk of product compromise and non-compliance with regulatory requirements.