U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad
The U.S. Food and Drug Administration issued four observations to Gland Pharma’s formulation facility near Hyderabad following an unannounced inspection. The observations, documented on Form 483, were made during an inspection that took place between October 12 and 23. Gland Pharma must address these findings to ensure compliance with manufacturing standards.