USFDA inspects Gland Pharma’s Dundigal facility
Drug Approval

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations

  • By IPP Bureau | July 26, 2024

Gland Pharma Limited has 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 22nd July, 2024 and 25th July, 2024.

The inspection was concluded with two 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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