U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad
The U.S. FDA has issued four procedural observations to Gland Pharma's formulation facility in Dundigal, India, following an unannounced inspection. The company stated these findings are not related to data integrity and that they are preparing corrective actions.
Why it matters
Regulatory scrutiny of pharmaceutical manufacturing facilities can impact drug supply chains and investor confidence in the healthcare sector.
U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad The four Form 483 observations followed an unannounced inspection on current good manufacturing practice at the facility in Dundigal between October 12 and 23 HYDERABAD The U.S. Food and Drug Administration (U.S. FDA) has issued four observations to Gland Pharma’s formulation facility near Hyderabad.
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