FDA EIR - Harmony Foods, LLC. dba SCN BestCo - December 18, 2014

Harmony Foods Corporation, operating as Santa Cruz Nutritionals, underwent a surveillance inspection by the FDA from December 16-18, 2014, at its Santa Cruz, CA facility. The company manufactures dietary supplement vitamins in gummy form, as well as non-supplement gummy candies. This inspection followed the regulatory framework of CPGM 7321.008 for Dietary Supplements. Notably, no FDA Form 483 (Notice of Observations) was issued during this inspection, which was classified as No Action Indicated (NAI). This positive outcome followed voluntary corrections made by Harmony Foods to all five issues identified in a previous September 2012 inspection, which included failures related to equipment maintenance, employee sanitation practices, handwashing facilities, quality control review of calibration records, and proper storage of quarantined dietary supplements. While no formal violations were cited, the FDA investigator discussed two key observations with management. First, batch production records were found to be missing identifying codes for scales used in ingredient weighing, though the firm had already drafted a revised form to address this. Second, and more critically, the firm was manufacturing a dietary supplement for a client using a botanical blend whose ingredients could not be fully identified, thereby preventing complete supplier qualification. Despite the client's exemption from identity testing for this blend, the FDA emphasized that this situation does not exempt Harmony Foods from dietary supplement requirements. The CEO indicated he would consider the necessary next steps.