U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad
The U.S. Food and Drug Administration (U.S. FDA) has issued four observations to Gland Pharma’s formulation facility near Hyderabad. The four Form 483 observations followed an unannounced inspection on current good manufacturing practice (cGMP) at the facility in Dundigal between October 12 and 23. The observations are procedural in nature and the corrective and preventive…
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