Bio Lab Naturals, Inc – FDA 483, Apr 13, 2023

An FDA inspection of Pure Solutions Inc. in Tampa, FL, revealed 10 significant deficiencies in their manufacturing of dietary supplements. The observations primarily highlight systemic failures in quality control, lack of established specifications for components and finished products, inadequate record-keeping, and poor facility maintenance. These issues collectively indicate a substantial deviation from good manufacturing practices, posing potential risks to product quality and safety.