FDA 483 - Gland Pharma Limited - May 16, 2019

An FDA inspection of Gland Pharma Limited, a parenteral drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately investigate unexplained discrepancies, including visible foreign materials in drug products and issues with unclean glassware. Additionally, the inspection identified shortcomings in aseptic processing environmental monitoring, equipment cleaning and sanitization procedures, and contamination control during material transfers.