FDA 483 - Gland Pharma Limited - March 31, 2017

Gland Pharma Limited, a sterile drug manufacturer in Duvvada, Visakhapatnam, was cited for significant deficiencies in its aseptic processing controls and quality system. Observations included inadequate environmental monitoring, insufficient investigations into manufacturing deviations and out-of-specification results, and failures in equipment maintenance and cleaning procedures. These issues indicate a lack of assurance in product quality and process control.