FDA 483 - GPC MEDICAL LIMITED - October 21, 2019

GPC MEDICAL LIMITED, a medical device manufacturer in Sonepat, India, was inspected by the FDA from October 21-24, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process control procedures, insufficient in-process product acceptance protocols, and a lack of established corrective and preventive action procedures. Additionally, the firm failed to adequately validate critical processes and maintain equipment schedules, indicating a systemic breakdown in quality management.