FDA 483 - Abeona Therapeutics, Inc. - March 01, 2024

An FDA inspection conducted at Abeona Therapeutics Inc. from February 19 to March 1, 2024, identified critical deficiencies in their manufacturing and quality control systems. Issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, the observations highlight concerns regarding the company's adherence to Good Manufacturing Practices for cell and gene therapy products. Main violations include inadequate controls over aseptic manufacturing processes, such as insufficient validation of media, components, and bioburden limits, compromising sterility assurance for the final product. The firm also failed to adequately control the quality of media and reagents, lacking proper sterility, endotoxin, and identity testing, and without validated expiry dates. Quality Assurance demonstrated inefficient management of deviations, leading to delayed investigations, inadequate risk assessments, and the release of product lots with out-of-specification results for clinical use without proper justification or confirmed root causes. Retesting procedures were unclear, permitting multiple retests without identifying underlying issues. Lastly, disinfectant efficacy studies were deficient, failing to qualify primary disinfectants or evaluate facility isolates. Abeona Therapeutics is required to promptly address these observations by implementing comprehensive corrective and preventative actions to ensure product quality and patient safety.