Generic injectable-focused Gland Pharma has received establishment inspection report (EIR) from the U.S. Food and Drug Administration for its facility in Dundigal, near Hyderabad.
The company has received EIR indicating closure of the inspection, Gland Pharma said in a filing.
The U.S. FDA had in July inspected the facility for good manufacturing practices (GMP) and issued two Form 483 observations. On conclusion of the inspection, the company had said the observations were procedural in nature and neither repeat observations nor related to data integrity.
Published – January 16, 2025 05:55 pm IST
