FDA 483 - Row1 Inc. dba Regenative Labs - March 30, 2022

Rowl Inc. dba Regenative Labs in Pensacola, FL, was cited for significant deficiencies during an FDA inspection of its human tissue establishment. The inspection revealed widespread issues with aseptic processing, process validation, environmental monitoring, and quality control for its umbilical cord tissue products. These findings indicate a severe lack of adherence to regulations designed to ensure product sterility, identity, strength, quality, and purity.