FDA 483 - Shanghai Ambiopharm Inc. - May 22, 2026

Shanghai AmbioPharm, Inc., a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written quality control procedures and quality agreements with third-party testers, unqualified and poorly managed manufacturing equipment, and incomplete master production and batch records. These issues indicate a systemic failure in maintaining adequate control over manufacturing processes and quality assurance.