FDA 483 - Evig LLC dba Balance of Nature - February 08, 2019

Evri LLC dba Balance of Nature, a dietary supplement own label distributor in Saint George, UT, was cited for multiple failures to establish and follow written procedures. These critical deficiencies include a lack of quality control procedures for contracted manufacturing, absence of procedures for investigating product complaints, and no procedures for handling returned dietary supplements. The inspection highlights significant gaps in their quality management system.