FDA 483 - Therapak Corporation - February 12, 2026

An FDA inspection of Therapak Corporation, a contract manufacturer in Claremont, CA, revealed significant deficiencies in their quality management system. The firm failed to properly utilize data analysis for improvement, specifically demonstrating erroneous statistical sampling for both receiving inspection and manufacturing of medical devices. Additionally, procedures for the feedback process, particularly regarding complaint handling and risk categorization, were found to be undocumented or improperly applied.