FDA 483 - Apozeal Pharmaceuticals Inc. - October 15, 2025

Apozeal Pharmaceuticals Inc. in Levittown, PA, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control, including failures to investigate discrepancies, inadequate cleaning validation, and insufficient laboratory and computer system controls. These issues indicate a lack of robust quality management systems for drug product manufacturing.