Spa De Soleil, Inc. – FDA 483, Jan 26, 2026

Spa De Soleil, Inc. in Sun Valley, CA, a drug product manufacturer, received a Form 483 with seven observations during an FDA inspection. The firm demonstrated significant deficiencies across material, production, laboratory, and quality control systems. These issues include failures in identity testing, OOS investigations, process validation, equipment cleaning, and quality unit responsibilities, indicating a lack of adequate controls to ensure drug product quality, identity, strength, and purity.