Americanna Wellness Inc – FDA 483, Oct 28, 2024

Americanna Wellness Incorporated in Bellingham, WA, a manufacturer of finished drug products, was inspected by the FDA. The inspection revealed significant deficiencies across its quality control unit, component testing, production and process controls, equipment qualification, and master production and control records. These issues indicate a lack of fundamental procedures and documentation necessary to ensure drug product identity, strength, purity, and quality.