USFDA inspected Gland Pharma's Visakhapatnam facility (19, 25 Feb 2025), issuing three procedural Form 483s unrelated to data integrity; CAPA submission planned.

• Gland Pharma operates globally in 60 countries with diverse injectable products.
• The company pioneered heparin technology in India, expanding its pharmaceutical footprint.
• Observations are non-repeated; CAPA to be submitted within the stipulated timeline as required by the USFDA.