FDA 483 - Abeona Therapeutics, Inc.

Abeona Therapeutics Inc. in Cleveland, OH, received an FDA Form 483 with five observations related to its cell and gene therapy manufacturing. The inspection revealed significant deficiencies in aseptic processing controls, quality control of media and reagents, deviation management, retesting procedures for lot release, and disinfectant efficacy studies. These issues indicate potential risks to product sterility and quality, including the release of product lots with out-of-specification results.