What happened
Original notice title
Far East Summit LLC MARCS-CMS 681536, September 13, 2024
From the archived source record
Based on our inspectional findings and our review of your product catalog and website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs and Misbranded Drugs During the inspection, we reviewed your website, www.fareastsummit.com, from which you take orders for your products Si Ni San, Du Huo Ji Sheng Tang, Ba Zheng Tang, and Xue Fu Zhu Yu Tang; and your product catalog, Far East Summit Product Listing and Order Form, which offers for sale your products Si Ni San, Bu Xue Tiao Jing Tang, Gan Mao Ling, Guan Jie, Huang Lian Shang Qing, Jin Gu Die Shang Wan, Shen Ling Bai Zhu San, Su Gan Wan, Tong Jing Tang, Xiao Jian Zhong Tang, and Xian Yao San. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Si Ni San, Bu Xue Tiao Jing Tang, Xian Yao San, and Su Gan Wan products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Dietary Supplement CGMP Violations The inspection revealed significant violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 0517e3afaed7
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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