FDA 483 - Green Water, LLC - July 26, 2018

Green Water, LLC, a manufacturer of "Taspen's Organics" brand herbal tinctures (dietary supplements) in Conifer, CO, was cited for a comprehensive lack of quality control. The inspection revealed the firm failed to implement essential quality control operations, establish product and component specifications, or maintain proper manufacturing and batch records. Additionally, the firm did not conduct identity testing for ingredients and lacked procedures for handling product complaints.