USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unit

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Gland Pharma Ltd's facility at Visakhapatnam received three Form 483 observations from the USFDA after a recent inspection for sterile APIs. The company stated that these observations are procedural and not related to data integrity. Corrective actions will be submitted to the USFDA within the given timeframe.