What happened
Original notice title
STPCA Inc. dba Sun Ten Laboratories MARCS-CMS 645336, April 07, 2023
From the archived source record
Based on inspectional findings and a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at the Internet address [see original source] in February 2023, and has determined that you take orders there for the products Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2. 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, Jian Shen, Xiao Yan, and Platcladus Leaves Ce Bai Ye 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)]. Adulterated Dietary Supplements The facility inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on these violations, your Lycium Formula Huan Shao Dan, (b)(4) Zinc (b)(4) , and (b)(4) products are 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. Your significant violations of CGMP requirements are as follows: 1. Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c).
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
- 82e4b98548c1
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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