FDA 483 - American Chinese Natural Herbs, Inc. - March 17, 2022

An FDA inspection of American Chinese Natural Herbs, Inc. in Garland, TX, a dietary supplement manufacturer, revealed multiple significant deficiencies. The firm failed to establish critical specifications for finished products, components, labels, and packaging, and did not adequately qualify suppliers. Additionally, the company lacked proper quality control procedures and failed to maintain complete batch production records, indicating a systemic lack of control over their manufacturing processes.