FDA 483 - Lanzhou Foci Pharmaceutical Co., Ltd. - March 20, 2025

An FDA inspection of Lanzhou Foci Pharmaceutical Co., Ltd. in Lanzhou, China, a dietary supplement manufacturer, revealed multiple significant deficiencies. The firm failed to establish product specifications for contaminants, use scientifically valid testing methods, verify dietary ingredient identity, and test components for impurities. Additionally, the inspection found inadequate equipment cleaning and maintenance, pest control issues, and plumbing cross-connections, indicating severe lapses in manufacturing controls.