FDA 483 - Ethical Nutritional, LLC dba Remedy Makers - December 05, 2024

Ethical Nutritional, LLC dba Remedy Makers in Pomona, CA, was cited for significant deficiencies in its manufacturing processes for homeopathic drug products. The inspection revealed a lack of essential written procedures for production and process controls, including validation, cleaning, supplier qualification, and recalls. Additionally, the firm demonstrated inadequate personnel, unqualified equipment, a deficient quality control unit, and a complete absence of stability testing and proper investigation of material failures.