FDA 483 - FORDOZ PHARMA CORPORATION - November 12, 2025

FORDOZ PHARMA CO. in East Windsor, NJ, a sterile drug manufacturer, was inspected and cited for significant deficiencies across its manufacturing processes. Key issues include inadequate validation of aseptic processes, poor aseptic techniques, deficient cleaning and environmental monitoring, and failures in quality control procedures and data integrity. These observations indicate a systemic lack of control over sterile drug product manufacturing and quality assurance.