FDA 483 - Nutrix International LLC - April 11, 2019

NUTRUX LLC in Salt Lake City, UT, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control testing for active ingredients and yield determination, as well as widespread issues with facility sanitation, storage practices, and contamination prevention in manufacturing and processing areas. These conditions indicate a lack of adequate controls to ensure drug product quality and prevent mix-ups.