FDA EIR - Harmony Foods, LLC. dba SCN BestCo - August 30, 2019

An FDA surveillance inspection of Harmony Foods Corporation, a manufacturer of dietary supplement gummies located in Santa Cruz, CA, was conducted from August 26 to August 30, 2019. The inspection, performed under the Dietary Supplement Current Good Manufacturing Practices (CGMPs) regulatory framework (21 CFR Part 111), identified several deficiencies. The primary issues noted in a Form FDA 483 included: 1. The company lacked adequate written procedures and consistent implementation for testing the strength of dietary ingredients in finished products, specifically regarding a statistically sound rotational testing plan. 2. Air-blowing equipment, such as a fan and an air conditioner unit, with accumulated dust, was observed blowing directly onto exposed dietary supplement gummies in production areas, posing a contamination risk. 3. Harmony Foods Corporation did not have established written procedures outlining the criteria for selecting standard reference materials used in their laboratory testing processes. Beyond these formal observations, several non-483 issues related to general sanitation and storage were also discussed. Harmony Foods Corporation acknowledged the findings and committed to promptly correcting all observations, including providing a detailed written response to the FDA within 15 business days.