FDA 483 - American Herbal Laboratories, Inc - September 10, 2021

An FDA inspection of American Herbal Laboratories, Inc. in Rosemead, CA, revealed significant deficiencies in their dietary supplement manufacturing processes. The firm failed to establish and adhere to proper specifications for identity, contamination, and finished product testing for both raw materials and final products. Numerous issues were also identified with their Master Manufacturing Records, including a lack of specific batch sizes, component weights, theoretical yields, and adequate verification procedures, indicating a systemic breakdown in quality control.