Sani-Care Salon Products, Inc – FDA 483, Jan 17, 2025

Sani-Care Salon Products, Inc. in Cartersville, GA, an own label distributor of drug products, received a Form 483 with nine observations during an inspection from January 13-17, 2025. The inspection revealed significant deficiencies in their quality control unit, including a lack of established procedures for quality oversight, complaint handling, annual product reviews, employee training, and proper record-keeping for production, laboratory controls, and distribution. Several observations were repeats from a previous inspection, indicating persistent issues with cGMP compliance, particularly concerning their contract manufacturing organizations and the handling of hand sanitizer drug products.