483
Pharmadax (Foshan) Co., Ltd (Heshun Plant)Pharmadax (Foshan) Co., Ltd (Heshun Plant) – FDA 483, Mar 11, 2019
Record Details
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.
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ID · 3e1ada08-4450-4379-9821-088e8b0617ce
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