FDA 483 - Herbal Vitality, Inc - July 15, 2022

Herbal Vitality, a dietary supplement manufacturer in Sedona, AZ, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple areas, including a lack of established product specifications, inadequate identity testing for dietary ingredients, incomplete master manufacturing records, and failures in quality control operations for batch release and review of test results. Additionally, the firm failed to collect and hold proper reserve samples, establish contamination limits, and qualify suppliers for components.