FDA 483 - Edge Biologicals Inc - April 04, 2023

An FDA inspection of Edge Biologicals Inc, a manufacturer of culture media devices, was conducted from March 20 to April 4, 2023, resulting in a Form FDA 483 with eight significant observations. These findings highlight systemic deficiencies in the company's quality system, which are critical for ensuring product safety and efficacy under the Federal Food, Drug and Cosmetic Act.Primary violations included a failure to validate critical manufacturing processes, such as cleaning of controlled environmental areas and sterilization of tubing sets, leading to potential product compromise. The company also failed to establish and effectively implement corrective and preventive action (CAPA) procedures, leading to inadequate investigation of product sterility failures and insufficient analysis of quality data. Supplier management was deficient, lacking defined controls and documented evaluations. Furthermore, Edge Biologicals Inc did not maintain Device Master Records for its products, failed to adequately control environmental conditions, and lacked procedures for product acceptance activities. The inspection also highlighted a complete absence of internal quality audits since 2019 and insufficient documentation of employee training.Many of these observations, particularly regarding CAPA, supplier controls, device master records, acceptance activities, quality audits, and training, were repeat findings from previous FDA inspections in 2015 and 2018, indicating a persistent lack of compliance. The owner, Walter C. Edge, Jr., promised to correct all noted observations. The firm is required to address these systemic issues through comprehensive corrective actions and internal audits to achieve compliance with regulatory quality system requirements.