Gland Pharma Limited announced that the United States Food and Drug Administration (US FDA) has concluded its pre-approval inspection (PAI) at the company’s JNPC facility in Visakhapatnam. The inspection, which took place from February 19 to February 25, 2025, resulted in three Form 483 observations.
According to the company, these observations are procedural in nature and are neither repeat observations nor related to data integrity. Gland Pharma has stated that corrective and preventive actions will be submitted to the US FDA within the stipulated timeframe.
The company has assured that the observations do not have any immediate financial or operational impact. The regulatory development follows standard compliance practices in the pharmaceutical industry, as companies regularly undergo inspections from global regulators to ensure adherence to good manufacturing practices.
Gland Pharma remains committed to addressing the observations and maintaining compliance with regulatory requirements to support its product approvals and operations in the US market.
