FDA 483 - Himalaya Wellness Company - May 24, 2024

An FDA inspection of Himalaya Wellness Company in Bengaluru, India, revealed significant deficiencies in the manufacturing of dietary supplements for export to the United States. The firm failed to ensure that its identity testing methods, specifically thin layer chromatography, were scientifically valid and utilized reliable reference standards. Additionally, the company did not establish adequate strength specifications for either its finished dietary supplements or their herbal components.