USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

The United States Food and Drug Administration (US FDA) has conducted a Pre-approval inspection (PAI) for Sterile APIs at the company’s Facility at JNPC, Visakhapatnam between February 19, 2025 and February 25, 2025.

The said inspection was concluded with 3 Form 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.