FDA 483 - FORDOZ PHARMA CORPORATION - March 17, 2023

FORDOZ PHARMA CO. in East Windsor, NJ, a sterile drug manufacturer, was cited for significant deficiencies across its manufacturing operations. Observations included inadequately designed and qualified equipment, unsuitable building construction and maintenance, and failures in aseptic process simulations and warehousing procedures. These issues indicate a lack of control over critical aspects of sterile drug production and storage.