FDA 483 - Global Vitality Inc. - April 24, 2019

Global Vitality, Inc. dba Enzyme Process International, a dietary supplement manufacturer in Chandler, AZ, received an FDA Form 483 citing numerous deficiencies. The inspection revealed significant issues with quality control operations, including failure to reject non-conforming raw materials and incorrect product labeling, as well as inadequate record-keeping for batch production and laboratory operations. The firm also failed to establish appropriate specifications for raw materials, in-process materials, and finished dietary supplements, with several repeat observations from a previous inspection.