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

American Herbal Laboratories, Inc. underwent an FDA inspection from August 25 to September 10, 2021. The surveillance inspection, conducted under 21 CFR 111 for dietary supplement Current Good Manufacturing Practices (cGMPs), identified 12 significant observations on an FDA Form 483, some of which were repeat violations from previous inspections. Key violations centered on quality control and manufacturing documentation. The company failed to conduct appropriate identity testing for dietary ingredients prior to use and lacked established specifications for limits on contamination (e.g., pathogens, pesticide residues, heavy metals) for dietary ingredients, with no finished product microbiological testing since 2018. Further, the firm did not establish comprehensive finished product specifications for identity and composition, nor identity specifications for each component. Deficiencies in Master Manufacturing Records (MMRs) were noted, including the absence of batch sizes, accurate component weights/measures, theoretical yields, and clear instructions requiring dual verification. Written instructions also lacked in-process specifications and detailed manufacturing steps. Additionally, the firm failed to collect retention samples of dietary ingredients. Beyond the 483 observations, the inspection highlighted labeling concerns, such as the absence of supplement facts on outer packaging and potential medical claims on the company's website. Quality control personnel were also found not to be properly approving batch records. President Luke Cua committed to providing written corrections for the observations and a response regarding the labeling issues within 15 business days.