FDA 483 - GD Group USA Co - January 23, 2020

GD Group USA Co in Bartlett, IL, a distributor, was inspected by the FDA from January 21-23, 2020, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions, complaint handling procedures, and the performance of quality audits. One observation related to complaint handling was noted as a repeat observation, indicating persistent issues.