Gland Pharma announced that the United States Food and Drug Administration (US FDA) has conducted surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) between 22 July 2024 and 25 July 2024.
The inspection was concluded with TWO (2) 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.
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