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Originitalia SRL, an Italian drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in May 2024, rendering their products adulterated. The company failed to test incoming active pharmaceutical ingredients (APIs) for identity before manufacturing over-the-counter products and improperly relied on supplier certificates of analysis without validating their reliability. The firm's June 2024 response to FDA findings was deemed inadequate because it lacked supportive documentation and evidence of corrective actions, with the company announcing only a freeze on OTC production for 2024 rather than addressing the underlying compliance deficiencies.