FDA 483 - Gland Pharma Limited - August 25, 2022

Gland Pharma Limited, a drug-device combination manufacturer in Hyderabad, India, received a Form FDA 483 for deficiencies in its quality system. The inspection revealed that the firm had not established adequate procedures for design control, specifically failing to define design input requirements and ensure scientific justification for its Icatibant Injection product. Furthermore, the company had not fully implemented its quality risk management procedure, leading to an incomplete identification of potential faults and hazards.