FDA 483 - Edge Biologicals Inc - November 22, 2024

Edge Biologicals Inc, a manufacturer of In Vitro Diagnostic Devices in Memphis, TN, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, process validation, finished device acceptance, and complaint handling. These issues led to out-of-specification products, microbial contamination, mislabeled products, and inadequate investigations into product quality concerns.