US FDA issues four observations to Gland Pharma's Hyderabad unit

The US Food and Drug Administration has issued four Form 483 observations to Gland Pharma's formulation facility at Dundigal near Hyderabad after an unannounced cGMP inspection from October 12 to 23. The company said the observations are procedural, neither repeat findings nor linked to data integrity, and corrective actions will be submitted on time.