FDA 483 - Gland Pharma Limited - February 25, 2025

Gland Pharma Limited, a sterile drug substance manufacturer in Parwada, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate cleaning and disinfection processes in aseptic areas, failures in procedures to prevent microbiological contamination, and a lack of established production and process controls. These issues led to product quality failures and un-implemented corrective actions, raising concerns about the validated state of their manufacturing processes.