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FDA identifies three procedural issues at Gland Pharma's Indian facility during a recent inspection.
The U.S. Food and Drug Administration (FDA) found three procedural issues during a recent inspection at Gland Pharma's facility in Visakhapatnam, India.
The inspection, which took place from February 19-25, focused on sterile active pharmaceutical ingredients.
Gland Pharma, which specializes in generic injectables, says the issues are not related to data integrity and will submit corrective actions as required.
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La FDA identifica tres cuestiones de procedimiento en las instalaciones indias de Gland Pharma durante una inspección reciente.