Gufic Biosciences Limited announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection at its manufacturing facility located in Pithampur, Indore.

The United States Food and Drug Administration (USFDA) conducted an inspection of the company's facility from October 15 to October 23, 2026. The inspection concluded with the company receiving a Form FDA 483 containing three observations.

The company confirmed that it will work closely with the USFDA and remains fully committed to addressing these observations comprehensively within the stipulated timeframe.