FDA 483 - Harmony Foods, LLC. dba SCN BestCo - August 30, 2019

An FDA inspection of Harmony Foods Corporation, a contract manufacturer in Santa Cruz, CA, revealed three significant observations. The firm failed to provide adequate documentation for dietary supplement strength testing specifications and lacked a sound statistical plan. Additionally, air-blowing equipment was not operated to prevent contamination, and the company did not establish proper laboratory control processes for selecting standard reference materials.