Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it should not be used as a proxy for a company’s overall quality.
Human Drugs
CGMP Deviations in Henan Lvyuan Inspection
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pharmaceutical ingredients.
