FDA 483 - Botanic Tonics, LLC - November 17, 2022

Botanic Tonics, LLC was cited for significant quality control and regulatory compliance issues during an FDA inspection. The firm failed to ensure finished product conformity to specifications, properly investigate customer complaints, and register as an acidified food manufacturer. Additionally, numerous deficiencies were noted in raw material control, product specifications, production controls, and record keeping for their Feel Free Plant Based Herbal Supplement.