FDA 483 - Pharmadax (Foshan) Co., Ltd (Heshun Plant) - March 11, 2019

Pharmadax (Foshan) Co., Ltd (Heshun Plant) in Foshan City, China, was cited during a Preapproval Inspection for its drug product manufacturing operations. Observations included deficiencies in equipment qualification, lack of final reports for validation/verification activities, and inadequate second-person verification of laboratory records. These issues indicate a need for improved quality system controls to ensure product quality and data integrity.