FDA 483 - Elevate Surgical - March 26, 2026

An FDA inspection of Elevate Surgical in San Diego, CA, an HCT/P Storage & Distribution Facility, revealed three significant observations. The firm failed to routinely inspect equipment for maintenance, lacked established procedures for facility cleaning and sanitation, and had an inadequate quality program that did not ensure appropriate CGTP procedures were maintained, reviewed, and revised, particularly concerning temperature monitoring of allografts.