FDA EIR - FP Nutraceuticals LLC dba FoodPharma - September 20, 2021

An FDA routine surveillance inspection of FP Nutraceuticals LLC, operating as FoodPharma, a contract manufacturer of candy, nutritional bars, and dietary supplement chews, took place from September 16-20, 2021. This inspection evaluated compliance with Current Good Manufacturing Practices (cGMPs) and Preventive Controls for Human Food (PCHF) under Compliance Programs 7303.040 and 7321.008, specifically citing 21 CFR 111.27(d)(3) and 21 CFR 117.10.The inspection identified two primary issues. First, an FDA-483 observation was issued for inadequate cleaning and sanitization of contact surfaces used in consecutive operations involving dietary supplements, specifically noting apparent red residue on utensils. Management promptly re-cleaned the utensils and conducted employee re-training on cleaning procedures. Second, a personnel practice concern was noted, where an employee with partially uncovered facial hair handled finished snack cups. Management took immediate corrective action by removing the employee, adding mirrors to gowning areas, and planning re-training for staff.The firm's management committed to submitting a written response detailing their corrective actions within 15 business days. No samples were collected, and no refusals were encountered during the inspection.