FDA 483 - Predictable Surgical Technologies - November 18, 2021

An FDA inspection of Predictable Surgical Technologies in Hebron, KY, a human tissue distributor, revealed significant deficiencies in their quality systems and procedures for handling Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to establish appropriate standard operating procedures for storage, receipt, and distribution of HCT/Ps, lacked a method for tracking distinct identification codes for distributed HCT/Ps, and did not have a comprehensive quality program addressing core CGTP requirements.