FDA 483 - Abeona Therapeutics, Inc.

An FDA inspection of Abeona Therapeutics Inc. in Cleveland, OH, revealed significant deficiencies in their cell and gene therapy manufacturing. Observations included inadequate aseptic process controls, insufficient quality control for media and reagents, and a severely inefficient deviation management system. These issues led to delayed investigations, inadequate risk assessments, and the release of potentially compromised product lots.