USFDA closes Dundigal inspection with four procedural observations
GLAND · price
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The USFDA inspected Gland Pharma's Dundigal formulation facility from October 12 to 23, 2026. The inspection ended with four Form 483 observations, which the company described as procedural, not repeated and not related to data integrity. Gland will submit corrective and preventive action plans within the required period and reported no quantifiable financial or operational impact.
No penalty, ban or quantified impact was disclosed. Regulatory risk remains, but the company calls the observations procedural and non-recurring.