FDA 483 - JW Nutritional, LLC - September 26, 2025

An FDA inspection of JW Nutritional LLC, a contract manufacturer of OTC drug products in McKinney, TX, revealed significant deficiencies in their manufacturing processes. The firm failed to establish adequate process validation for drug products, ensure complete component testing for raw materials, and properly qualify equipment, specifically their water system. These issues indicate a lack of control over critical manufacturing operations and product quality.