FDA 483 - New Spirit Naturals Inc. - August 24, 2021

New Spirit Naturals Inc. in San Dimas, CA, a dietary supplement and juice manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in establishing product specifications for dietary supplements, controlling for contaminants, and maintaining complete batch production records. Additionally, the firm's hazard analysis and HACCP plan for juice products were found to be inadequate, lacking proper identification of hazards and control measures for pathogen reduction.