FDA 483 - World Club Supply Corp - November 03, 2020

World Club Supply Corp in Orange, CA, was cited for numerous deficiencies across its production, quality, and laboratory control systems during an FDA inspection. The firm lacked adequate process validation, change control, and stability testing for its antibacterial soap and hand sanitizer products. Additionally, issues included deficient batch records, uninvestigated out-of-specification results, and uncalibrated equipment, indicating significant GMP non-compliance.