Vitality Works, Inc – FDA 483, Aug 5, 2022

Vitality Works, Inc. in Albuquerque, NM, received a Form 483 with seven observations during an FDA inspection. The firm demonstrated significant deficiencies in quality control, including inadequate component testing, unvalidated manufacturing processes for homeopathic drug products, and insufficient investigation into environmental monitoring excursions. These issues indicate a lack of adherence to cGMP standards, potentially impacting the identity, strength, quality, and purity of their drug products.