The U.S. Food and Drug Administration (U.S. FDA) has issued a Form 483 with four observations to Natco Pharma after inspecting the generic drugmaker’s finished dosage formulations (FDF) unit in Visakhapatnam.

The U.S. FDA had conducted the inspection from August 17-21. Natco Pharma said it believes the observations are procedural in nature and is confident of addressing them comprehensively within stipulated timelines.