FDA EIR - Harmony Foods, LLC. dba SCN BestCo - June 09, 2016

An FDA inspection of Harmony Foods DBA Santa Cruz Nutritionals LLC, a gummy food and dietary supplement manufacturer, occurred from June 2-9, 2016. Initiated by the Coordinated Outbreak Response and Evaluation Network (CORE) due to consumer illness complaints linked to the firm's manufactured gummy chews, the inspection adhered to Compliance Program Guidance Manuals for Dietary Supplements and NLEA labeling, classifying products under the Food, Drug and Cosmetic Act. While no formal FDA Form 483 observations were issued, several critical issues were identified and discussed with management. These included uncovered molds during gummy production and transport, a line supervisor not following hygiene protocols by wearing a ring and no gloves near equipment, wooden pallets placed too close to open products, and residue on packaging machine food contact surfaces. Furthermore, environmental monitoring revealed microbial positives on floors and drains, necessitating corrective actions. Management committed to installing covers for molds, retraining staff on hygiene and appropriate pallet distances, and acquiring plastic pallets. The packaging machine residue was promptly cleaned and employees retrained during the inspection. The firm was also actively collaborating with its customer and conducting extensive testing to determine the root cause of the consumer illness complaints.