FDA 483 - Global Vitality Inc. - July 28, 2021

An FDA inspection of Global Vitality, Inc. dba Enzyme Process International revealed significant and repeat deficiencies in quality control and manufacturing processes. The firm failed to ensure scientifically valid test methods, maintain complete and accurate batch production records, and adhere to basic hygienic practices, leading to the release of products that did not meet established specifications. These systemic issues, many of which were repeat observations from prior inspections, indicate a critical lack of compliance with good manufacturing practices.