FDA 483 - Elevate Surgical - March 04, 2019

An FDA inspection of Sports Tek Medical Inc. in Honolulu, HI, revealed significant deficiencies in their HCT/P storage and distribution operations. The firm lacked a comprehensive quality program and essential procedures, leading to issues with appropriate storage temperatures for HCT/Ps and inadequate record retention practices. These observations indicate a failure to meet core CGTP requirements.