U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad
The four Form 483 observations followed an unannounced inspection on current good manufacturing practice at the facility in Dundigal between October 12 and 23
The U.S. Food and Drug Administration (U.S. FDA) has issued four observations to Gland Pharma’s formulation facility near Hyderabad.
The four Form 483 observations followed an unannounced inspection on current good manufacturing practice (cGMP) at the facility in Dundigal between October 12 and 23. The observations are procedural in nature and the corrective and preventive actions will be submitted to the U.S. FDA within the stipulated period.
The observations issued are neither repeat observations nor related to data integrity, the company said in a filing on Friday (October 24, 2026).
Gland Pharma shares closed 1.17% lower at ₹2,825.35 apiece on the BSE.
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