FDA 483 - Gland Pharma Limited - February 25, 2025

An FDA inspection of Gland Pharma Limited in Parawada, India, a sterile drug substance manufacturer, revealed significant deficiencies across three observations. The firm was cited for inadequate cleaning and disinfection practices in aseptic processing areas, failures in procedures to prevent microbial contamination, and a lack of adequate written procedures for production and process controls. These issues indicate a compromised state of control over critical manufacturing processes for sterile drug substances.