FDA 483 - Green Roads, Inc. dba Clarity Labs - June 17, 2022

An FDA inspection of Green Roads, Inc. dba Clarity Labs, an OTC drug manufacturer in Miami, FL, revealed significant deficiencies in their manufacturing processes. The firm failed to establish control procedures for process validation, adequately test drug products to determine expiration dates, and fully implement quality control unit procedures for OTC drug products. These issues indicate a lack of robust quality systems for ensuring product quality and stability.