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Edge Biologicals Inc., a Memphis-based manufacturer of in vitro diagnostic devices, failed to comply with Current Good Manufacturing Practice (CGMP) requirements under the Quality System regulation. During a March-April 2023 inspection, FDA investigators identified critical failures including inadequate validation of cleaning processes for controlled environmental areas used in aseptic processing of culture media and failure to validate sterilization procedures for tubing sets used in aseptic fill operations. These violations rendered the company's Class I and Class II medical devices adulterated, with the sterilization validation failure noted as a repeated observation from a prior inspection.