FDA 483 - Gland Pharma Limited - November 01, 2019

An FDA inspection of Gland Pharma Limited, a sterile drug manufacturer in Visakhapatnam, revealed two significant observations. The firm failed to adequately validate its aseptic and sterilization processes, raising concerns about microbiological contamination control. Additionally, investigations into unexplained discrepancies lacked thoroughness, conclusions, and follow-up actions.